Category Archives: Eye Information

Ozempic and Eye Problems

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Ozempic and retina problems

anatomy of the eye

What is the issue of Ozempic and eye problems?

Many people are prescribed Ozempic (and related medications) for type 2 diabetes mellitus and weight loss. There are reports of increased risk of diabetes-related retina complications after starting Ozempic. Complications include loss of vision (usually, not permanent when treated), vitreous hemorrhage, macular edema, and the need for laser treatment or injection treatment for diabetic retinopathy. There is also an association of Ozempic and ischemic optic neuropathy.

How does Ozempic cause eye problems?

It appears that Ozempic does not directly cause damage to the eyes. Rather, Ozempic may cause rapid lowering of blood sugar (especially, when used with other medications for diabetes). It is well-known that any treatment that rapidly lowers blood sugar may initially cause a worsening of diabetic retinopathy. It is as though the retina becomes adjusted to higher-than-normal blood sugars in diabetes. And then, when blood sugars drop, the retina becomes “starved.” The effect wears off as the retina becomes used to the lower blood sugar levels. Furthermore, in the long-run, the retina will be healthier with improved blood sugar control.

Who is at risk for retina problems and loss of vision with Ozempic?

Risk factors for retina problems from Ozempic include: prior damage from high blood sugar (diabetic retinopathy), rapid lowering of blood sugar, and continued use of other diabetes medications. Eyes with crowded optic discs (from small scleral opening or optic disc drusen) from birth are at increased risk of optic nerve damage.

What can I do to prevent loss of vision with Ozempic?

If you have diabetes, see an ophthalmologist (or better yet, a retina specialist) for an eye exam before starting Ozempic. If you already have vision-threatening changes, early treatment will prevent worsening with Ozempic. In addition, routine monitoring of the retina during treatment with Ozempic may prevent permanent loss of vision from diabetic retinopathy. In addition, the optic nerve may be evaluated to determine if it is at risk of ischemic optic neuropathy.

By: Scott E. Pautler MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

Copyright  © 2024 Designs Unlimited of Florida.  All Rights Reserved.

Will I Lose Vision from AMD?

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Will I lose vision from AMD?
anatomy of the eye (click on image to enlarge)

What are the risk factors of losing vision?

If you have been diagnosed with AMD, you may ask, “Will I lose vision from AMD?” There are many risk factors that lead to the worsening of age-related macular degeneration (AMD).  Some are genetic (inherited) and some are environmental.  However, one the greatest risk factors is age.  This is, the older you are with AMD, the greater the risk of loss of vision.  Genetic testing can reveal high risk genes, such as CFH and ARMS2.  Therefore, a family history of vision loss from AMD increases your risk.  Other important factors that affect the risk of losing vision include tobacco use and diet.

What are the stages of AMD?

There are several stages of AMD that affect the risk of severe loss of vision: early, intermediate, and late AMD.  Early AMD presents with medium sized deposits under the retina called drusen.  These eyes usually have no symptoms and the vision is good.  Intermediate AMD have large drusen and/or brown pigmentary changes under the retina.  These changes frequently result in slow recovery from bright light (like coming in from outdoors) and the need for good lighting while reading.  Late AMD causes distortion of straight lines and blind spots in the vision from geographic atrophy (loss of retinal tissue) and/or neovascularization (new blood vessels grow under the retina that bleed and cause blind spots from scar tissue).  Geographic atrophy is also called advanced dry AMD, whereas neovascularization is called wet AMD.  

How can I determine my risk of late AMD with vision loss?

A point system has been developed to determine your risk of loss of central vision from late AMD.  Exam findings in each eye are given a point value.  Then, all the points are added together from the two eyes to arrive at risk of progression to late AMD within 5 years.  

Exam FindingPoint Value
medium drusen0.5
large drusen1
pigmentary changes1
geographic atrophy or neovascularization2
Add the points from findings in each eye
From: Ferris FL 3rd, Wilkinson CP, Bird A, et al. Clinical classification of age-related macular degeneration. Ophthalmology. 2013;120(4):844-851. doi:10.1016/j.ophtha.2012.10.036

At total score of 1 yields a low risk of late AMD of under 5% in five years.  With 2 points, the risk is 12 percent.  Three points means a risk of 25% at five years.  And 4 points means there is a 50% chance of late AMD in five years.  Another way to calculate your risk of late AMD is to use an online calculator.  

How bad can the vision fall from late AMD?

Late macular degeneration may cause a large blind spot in the center of the vision in both eyes.  Although this renders an individual legally blind, it is important to remember that it is extremely rare to lose all vision from AMD.  The peripheral vision usually remains strong and this allows a person to get around a room and care for himself independently.  

Does everyone lose most of their central vision in late AMD?

No.  Many people retain useful vision.  Patients with advanced dry AMD may be treated with Syfovre or Izervay to slow the progression of geographic atrophy.  There are a host of medications that slow the loss of vision from wet AMD, including Avastin, Lucentis, Eylea, Beovu, and Vabysmo.  There is high expectation that further developments from ongoing research will offer even better odds of retaining useful vision in the future.  Those patients who do lose vision from AMD can be helped with low vision aids.  

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

Copyright  © 2023 Designs Unlimited of Florida.  All Rights Reserved.

The Smudged Contact Lens

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smudged-contact-lens
The contact lens rests on the cornea (see anatomy of the eye)

Blurred vision due to smudge on the contact lens?

There are many causes of blurred vision.  Sometimes, the eye doctor needs to update the power of the contact lens.  At other times, there may be an eye disorder that requires diagnosis and treatment by an ophthalmologist.  However, a smudged contact lens may be the problem.  To find out, remove and inspect the contact lens for a smudge.  

What are the causes of a smudge on the contact lens?

Many things may cause a smudge on the contact lens.  A factory defect is rare and the contact lens specialist usually detects damaged lenses prior to dispensing.  Makeup, creams, oils, or moisturizers on your fingers may cause the contact lens to be smudged.  A moisturizer in your hand soap may cause blurred vision by smudging the lens.  

What can be done to prevent smudges on the contact lens?

Proper contact lens maintenance and hygiene is important.  Follow all instructions given by your contact lens provider to the letter.  Make sure to wash your hands with hand detergent without moisturizers prior to inserting your contact lenses.  This is very important to keep your lenses clear and free of germs that can cause serious infection.

How do you remove a smudge from a contact lens?

The management of a smudged contact lens depends, in part, on the type of contact lens you wear.  If you use daily-wear contact lenses, it may be best to dispose of the smudged contact lens and replace it with a new lens.  When wearing lenses made to wear for longer than a day, carefully clean them daily by following the manufacturer’s recommendations. 

Rigid gas-permeable lenses are made for long-term use.  If they become smudged, gently rinse them with conditioning solution or a cleaning solution.  If this fails, an enzymatic cleaner may help.  Follow all instructions on the contact lens product recommended by your doctor.  Professional polishing is available by your contact lens provider.    

Where do I go for urgent care? 

If you have pain while wearing your contact, remove it immediately. If your eye remains blurred after you remove the contact lens, you may have a damaged cornea.  Make a prompt appointment with your eye doctor.  If you have pain or persistent foreign-body sensation (a feeling like sand in the eye), notify your eye doctor without delay.  If you are unable to contact your eye doctor and there is significant pain and/or loss of vision, report to the hospital emergency department urgently. 

By Scott E. Pautler, MD

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Why you look up when walking in the dark?

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Have you wondered why you look up when walking in the dark?  There is an anatomic explanation for this behavior.  To understand this issue better we will give a brief anatomy lesson.  

Anatomy of the eye. Image courtesy of Caitlin Albritton.

How is the eye is like a camera?

The eye is like a spherical camera.  The image above is an artistic version of an eye with the top half removed to reveal the inside anatomy.  The eye works by allowing light to enter the eye through the clear cornea.  The light then passes through the pupil, the circular opening in the iris.  The rays of light are focused by the lens, which lies behind the iris.  Light then travels through the clear vitreous gel that fills the eye.  The focused beam of light finally strikes the retina, which is like the film, or CCD array, in the back of a camera.  The retina contains receptors (photoreceptors) that detect light and then send a tiny electrical signal to the brain for interpretation.  

What is the difference between the rod and cone receptors?

There are two main types of retinal photoreceptors used for vision: cones and rods.  The cones work best in bright illumination and detect color.  The rods work best in dim illumination and do not detect color.  The rods are the photoreceptors used to navigate at night in dim light.  As it turns out, the retinal photoreceptors are not distributed across the retina evenly.  Most of the cones are located in the macula…the center of the retina.  This is the area of the retina that humans use to see sharp details with good color perception during the daytime.  When you look directly at an object, light reflected from its surface is directed onto the macula.  

Where in the retina are the rods and cones located?

The rods are located in the retina around, but not in the macula (the center of the retina).  Therefore, your best night vision is not provided by the central retina.  Indeed, many notice they see stars in the night sky the best if they look slightly off center from the area of interest.  Furthermore, the concentration of rods in the retina is greater above the macula than below the macula (Curcio, 1990).  Consequently, the best vision for walking at night is when the eyes look slightly up.  In this position, dim light from the path ahead falls onto the retina above the macula, where the rods are able to process the image much better than the cone-rich macula.  

Why did the human eye evolve this way?

Presumably, evolutionary pressure helped create this anatomical situation.  Even during the daytime, the amount of light entering the eye varies with gaze direction.  When looking straight ahead on a sunny day, more light enters the eye from above than from below the midline.  Light reflected from the ground is dimmer than light entering the eye from the sun above.  So even in the daytime, vision is aided by having more rod photoreceptors in the top half of the retina than from the bottom half.  Remember, light from below the eye, strikes the top part of the retina and light from above the eye strikes the bottom part of the retina.  Thus, due to the optical qualities of light and the anatomy of the eye, you may find yourself looking upward when walking around in the dark.  

By Scott E. Pautler, MD

Copyright  © 2022-2023 Designs Unlimited of Florida.  All Rights Reserved.

Computer Glasses

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Having trouble seeing the computer screen?

Do you have difficulty seeing the computer with your glasses?  Do you have difficulty keeping your head positioned to focus the progressive lenses on details at near?  Do your eyes feel fatigued after working on the computer?  You are not alone and there is a solution to your problem.  The problem frequently lies with the limitations of progressive lenses used to treat presbyopia.

What is presbyopia?

Presbyopia means “old eyes.”  It is the name given to the inability to focus at near that comes on with age.  Early in life, the eye has the ability to focus at distance and near with ease.  This property is called accommodation.  That is, the lens of the eye can change shape to alter the focus of the eye to adjust to different distances.  Therefore, presbyopia is the loss of accommodation due to the inability of the lens to change shape with age.  

Typically, when people reach the age of forty or fifty, if the eyes are focused at distance (either naturally or with glasses/contact lenses), the vision at near becomes difficult.  At that point, you need longer arms or “reading glasses” (also called, “cheaters”).      

What are readers, bifocals, trifocals, and progressive lenses?

There are a variety of lenses designed to treat presbyopia.  If a person has “normal” eyes focused at distance without glasses, standard over-the-counter reading glasses are used to treat presbyopia.  If a person needs glasses for distance vision, bifocal lenses are sometimes used. Bifocal lenses are designed with two lens segments.  The top segment is focused at distance and the bottom lens segment is focused at near.  There is usually a visible line on the lens that separates the top section from the bottom section.  The bifocal lens is helpful, but is limited by an inability to focus at an intermediate distance.  That is, the top section of the lens focuses well at 20 feet and beyond.  And the bottom section focuses well at near.  But the intermediate distance between distance and near is blurred for presbyopic eyes.  

So, trifocal lenses were developed.  Trifocals use a third lens segment.  The segment is located just below the distance segment and above the near segment to provide help with focusing at the intermediate distance.  Trifocals can be difficult to use.  It takes time to learn which lens to use for which distance (by tilting the head back the right amount).  And the intermediate lens power is less than ideal for focusing within the intermediate distance of three to twenty feet.  

Then came progressive lenses.  Progressive lenses are the most expensive lenses.  They are made to provide a top section of the lens for distance vision and this works well.  However, there is a compromise made in the lens in order to improve the focus in the intermediate and near range.  Specifically, the lens is molded to provide a narrow section of the lens leading from the top (distance) and bottom (near) sections of the lens.  This allows for accurate focusing at any point in the intermediate range (3-20 feet) as the head is tilted back slowly to find the appropriate section of the progressive lens to focus at any distance needed.  It takes time to learn how to hold the head in proper position to focus at intermediate and near distances in part because the zone of clear vision through the molded lens is very narrow.  Herein lies the difficulty with using progressive lenses for computer work.

How are my progressive lenses giving me trouble at the computer?

Viewing the computer screen presents unique challenges.  First, the screen is situation two to three feet from the eyes.  Second, the screen is broad and requires some degree of scanning across the screen.  The progressive lens is not designed well to solve these challenges.  While the progressive lenses work well for routine use of the eyes, the narrow zone of focus of the lens at intermediate and near distances requires constant fine movement of the head to keep the image in focus across the breadth of the computer screen.  This effort causes fatigue and frustration.

What is the solution?

While some people can tolerate the limitations of progressive lenses while working on the computer, others require a different type of lens.  Computer glasses may be prescribed that employ the less expensive bifocal lens style.  The top part of the bifocal is focused on the computer screen (rather than for distance) and the bottom part of the bifocal is focused for deskwork.  This lens avoids the narrow bridge of focus that limits the progressive lens.  That is, the entire top lens is focused for scanning the computer screen.  Similarly, the entire bottom portion of the computer glasses (bifocal) is available to scan papers on the desk. 

To facilitate the process of obtaining computer glasses, I recommend an individual use a tape measure to record the number of inches from your forehead to the computer screen.  Similarly, measure the distance to the desk for near work.  With these measurements in hand, the optometrist or ophthalmologist can prescribe precise bifocal glasses for computer and near work.  These computer glasses will not work for distance vision, but will likely relieve the frustration and fatigue when working at the computer for an extended period of time.

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

Copyright 2022. Designs Unlimited of Florida. All Rights Reserved.

The Far-Sighted Eye

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globe anatomy
anatomy of the eye (click on image to enlarge)

What is hypermetropia?

A hypermetropic eye is a far-sighted eye.  Without glasses the vision may be good at distance or blurred, but the vision is usually blurred or strained at near without glasses.  Hypermetropia is different from presbyopia (aging eyes).  Hypermetropia affects many people and is treated with glasses, contact lenses, and, rarely, laser surgery.  It is a common underlying reason for the need to wear optical correction (glasses).  

What causes hypermetropia?

Hypermetropia is an inherited condition that usually develops in childhood or early adulthood.  The eye develops with either a flat cornea or a short eyeball length, or both.  As a result, the image entering the eye is focused behind the plane of the retina.  In this case, the eye tries to focus the lens to make the image projection sharp.  Sometimes, the natural lens in the eye can compensate for the focusing of images, but often eyeglasses or contact lenses are needed.  The outer appearance of the eye is not usually changed.  It is not obvious that an eye is hypermetropic by inspecting the outside of the eye.       

Why is it important to know about hypermetropia?

Although most people with hypermetropia do not develop complications, some far-sighted people are at increased risk of losing vision from narrow-angle glaucoma, central serous choroidopathy (also known as central serous retinopathy), and choroidal effusion.  

Angle-Closure Glaucoma is a condition in which the pressure inside the eye damages nerve tissue that helps you see.  High pressure is the result of closure of the internal drain in the eye.  The pump inside the eye does not sense the closure of the drain; it continues to pump fluid into the eye.  The drain cannot keep up with the pump, so the pressure inside the eye rises.  This pressure may or may not cause pain or discomfort.  Over time, the pressure slowly takes away the side vision.  If undetected and untreated, it may cause total, irreversible blindness.  The best way to diagnose glaucoma is to have regular eye exams each year with pressure measurements and gonioscopy.  Treatment is effective in preventing vision loss.  Laser is often used to open the drain.  Sometimes operative surgery is required with or without removal of the lens in the eye (to make more room for the drain to stay open).  Often, eye drops are needed long-term to keep the pressure under control.

Central Serous Chorioretinopathy is an uncommon cause of vision loss from hyperopia.  The retina is a thin layer of delicate nerve tissue that lines the inside wall of the eye like the film in a camera.  In the eye, light is focused onto the retina, which “takes the picture” and sends the image to the brain.  In hypermetropic eyes, the layer under the retina called the choroid becomes crowded and thickened.  The outer coat of the eye known as the sclera may be thickened as well.  As a result of thickened choroid and sclera, the flow of fluid inside the eye that normally drains out through these structures, is restricted.  This fluid may then collect under the retina and cause the central vision to become blurred or distorted even with proper glasses.  Distortion is when straight lines look wavy or crooked.  Blood vessels under the macula may bleed causing sudden blurring, blind spot, or distortion.  Any of these symptoms should be reported to the eye doctor without delay, as early treatment with laser may prevent further loss of vision.

Choroidal Effusion is a separation of the choroid from the sclera, the wall of the eye. This is different from retinal detachment.  When the choroid detaches, it is no longer in proper position inside the eye.  As a result, symptoms of a dark curtain or shadow slowly starts off to the side and takes away the vision as the choroid detaches.  Pain is not common.  The diagnosis is made by a retinal specialist; it is critical to identify and differentiate choroidal detachment from retinal detachment and tumors.  Treatment of choroidal effusion is typically started with medications.  Sometimes, however, surgery is needed.  

Will refractive surgery help prevent these complications of hypermetropia?

Although refractive surgery (laser correction) is effective at changing the shape of the cornea to help eliminate the need for corrective lenses (glasses and contacts lenses), it does not restore the natural shape of the eye.  Therefore, it is still necessary to be aware of the warning signs of possible complications from hypermetropia.

What should a hypermetropic patient do?

Using your eyes to read or work at a computer will not weaken them.  Remember to have your eyes examined once a year with special attention to the opening of the drainage apparatus (the corneoscleral angle).  Not all eye doctors are proficient with determining the risk of angle-closure glaucoma; therefore, consider seeing a fellowship-trained glaucoma specialist if needed.  In Tampa there are several choices including doctors Levitt, Gamell, Richards, King, and Fridman.  Apart from an annual exam, report the following symptoms to your eye doctor without delay:

Sudden-onset pain in the eye (sometimes, associated with nausea)

Sudden-onset redness (especially, if associated with pain and blurred vision)

Loss of side-vision (possibly, a very late sign of glaucoma)

By Scott E. Pautler, MD

 
Copyright  © 2022 Designs Unlimited of Florida.  All Rights Reserved.

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

 

Portable Low-Vision Magnifiers

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There are various eye conditions that may result in loss of vision with limited potential for recovery with treatment.  In these situations, good lighting and magnifiers are essential for making best use of low vision.  Magnifying glasses and large closed-circuit TV magnifiers are large and heavy.  They are most useful for home use.  However, away from home, these devices may be too cumbersome.  An ideal solution to the problem, is the portable digital magnifier.  The small magnifiers are lighter than an old-fashioned magnifying glass and are easily transportable.  And, certainly, they may be used around the home, as well.

A number of my patients endorse the portable low-vision magnifiers listed below.  They come in various sizes depending on your needs and the size of your carrying bag.  They also vary in the amount of magnification provided.  They are particularly helpful when shopping for brands and prices in the grocery store.  Reading a menu at a restaurant is made much easier with these devices.  The added independence gained with a proper magnifier makes my patients less dependent on others for help and adds to their quality of life.    

Please refer to the links below for pricing on Amazon:

Small Portable Magnifier with 3.5″ screen with up to 25x zoom magnification

Large Portable Magnifier with 5″ screen with up to 32x magnification

Large Portable Magnifier with 5″ screen with up to 48x magnification and voice prompt function.

By Scott E. Pautler, MD

Note: This blog is supported by its readers via small commissions that may be earned through these links.  The commissions do not increase the price you pay and do not affect the content of this article.  Thank you for your support.  

Yosemite and Rhine Studies: an editorial

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Faricimab was recently approved by the FDA for the treatment of diabetic macular edema (DME). It is the first drug which simultaneously blocks vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang 2). The anti-VEGF-A action is shared with bevacizumab, ranibizumab, and aflibercept; and stabilizes microvascular permeability and inhibits neovascularization. The Ang 2 inhibition works via the angiopoietin and Tie signaling pathway to reduce microvascular permeability by a pathway independent of VEGF-A blockade. Preclinical studies suggested that faricimab might be more effective than simple anti-VEGF inhibition in treating diabetic macular edema. In particular, there were expectations for improvement over the status quo in duration of action. If similar efficacy with lesser treatment burden were possible, this would help overtaxed clinicians and patients and begin to close the real-world versus randomized trial performance gap.1

The results of two identical, phase 3 randomized clinical trials, YOSEMITE and RHINE, were recently published, allowing clinicians the opportunity to assess how the efficacy of faricimab matches the promise of the preclinical studies.2 There were 3 groups in the randomization: faricimab 6 mg q 8 weeks (F8), faricimab 6 mg with a personalized treatment interval (FPTI), and aflibercept 2 mg q 8 weeks (A8). The study authors reported the following in their paper:

  1. With A8 as the comparator, both F8 and FPTI were noninferior (4 letter margin) based on a primary outcome of mean change in best-corrected visual acuity at 1 year, averaged over weeks 48, 52, and 56.
  2. There were no differences in safety events among the 3 groups.
  3. In the FPTI group, more than 70% of patients achieved every-12-week dosing or longer at 1 year.
  4. Reductions in CST and proportions of eyes without center-involved DME (CI-DME) over 1 year consistently favored faricimab over aflibercept.
  5. Faricimab demonstrated a potential for extended durability in treating CI-DME.

Based on the evidence in the paper, are the claims substantiated? 

With respect to noninferiority of mean change in best corrected visual acuity, the answer is qualified by the authors’ method of measurement. Because the three groups got last injections at different times, there was no single visit for which assessment of final visual acuity was intuitive. Therefore, the authors averaged the visual acuities measured at 48, 52, and 56 weeks. For the F8 group, the 3 components of the average were 4 weeks post-injection (the measurements taken at 48 weeks), 8 weeks post-injection (the measurements taken at 52 weeks), and 4 weeks post-injection (the measurements taken at 56 weeks), implying that the average last visual acuity was at 5.33 weeks post-injection ([4+8+4]/3=5.33). For the A8 group, the 3 components of the average were 8 weeks post-injection (the measurements taken at 48 weeks), 4 weeks post-injection (the measurements taken at 52 weeks), and 8 weeks post-injection (the measurements taken at 56 weeks), implying that the average last visual acuity was at 6.66 weeks post-injection ([8+4+8]/3=6.66). That is, the A8 group was disadvantaged relative to the F8 group by virtue of the F8 group having more injections in the first year, and an injection nearer to the outcome measurement times. This issue might have been averted had the F8 group received the same 5 initial monthly injections as the A8 group.    

It is difficult to provide an analogous comparative calculation for the FPTI group. The relevant information is depicted in figure 3B, but the scale of the figure is microscopic, and only estimates can be made. For example, the YOSEMITE panel of figure 3B, the red-boxed subgroup, appears to comprise 63 patients. For these patients, the 3 components of the average were 16 weeks post-injection (the measurements taken at 48 weeks), 4 weeks post-injection (the measurements taken at 52 weeks), and 8 weeks post-injection (the measurements taken at 56 weeks), implying that the average last visual acuity was at 9.3 weeks post-injection ([16+4+8]/3=9.3). Likewise, for the RHINE panel of figure 3B, the red-boxed subgroup, appears to comprise 67 patients with the average last visual acuity at 9.3 weeks.  At the other extreme of the figure (the bottom) sits the group of eyes that could never be extended beyond 4 weeks.  For YOSEMITE and RHINE this group appears to comprise 19 and 23 patients, respectively. The average last visual acuity for these eyes would be 4 weeks. In between these extremes of the figure, one would need to do an analogous calculation for every row in the figure, pooling all the results for an overall average. This is clearly more than a reader can be asked to do. The authors should have done it and reported the result in the paper, to allow the reader to see if the outcome time for the FPTI group is comparable to the A8 group. The suspicion is that they are not comparable.

Regarding the claim that the safety results of the three groups were equivalent, we agree with the authors’ interpretation. There is no evidence that faricimab is less safe to use over the 52 weeks of follow-up reported.

The authors claim that over 70% of the FPTI group were able to enter the q 12 week dosing interval. The specific term they chose was “achieved” to signal this distinction. However, entering 12 week dosing is different from demonstrating that faricimab can sustain such intervals. The primary outcome at 52 weeks did not give enough time to determine if those eyes entering 12 week or longer durations could sustain that performance, or whether they would regress to require shorter interval injections. In YOSEMITE, 169 eyes (59%) and in RHINE, 172 eyes (56%) completed one 12wk interval to be assessed for successful completion. The reader has no idea if this proportion will be sustained in the second year of the trial, and it would be an unfounded assumption to expect the entrance to q12 week intervals to be maintained. This outcome will be of great interest when the 2-year results are reported. Only 22%/21% (Yosemite/Rhine) actually completed a 16-week interval and none were treated long enough to determine sustainability of this interval.

Another problem with the authors’ claim on duration of effect has to do with a form of spin, specifically type 3 spin, in the classification of Demla and colleagues.3 A reader might think that this achievement by faricimab distinguishes it from aflibercept, but that inference would not be warranted because of the study design. There was no aflibercept personalized treatment interval arm of the randomization, which would be required to make a claim that increased duration between injections was an advantage of faricimab. While true that a drug company investing in faricimab has no obligation to provide an opportunity for the competitor’s comparator drug to perform as well, the authors cannot claim that the feature displayed by faricimab is a differentiator worthy of a clinician’s choice as a deciding factor in the question of which drug to use. It is also true that the authors don’t make this claim differentiating the drugs, but in presenting asymmetric evidence as they do, an erroneous inference is easy to make, which we seek to avert.

The authors’ claim of superior drying effectiveness for faricimab is supported by the presented data, but unremarked by the authors was evidence of similar durations of drying action of faricimab and aflibercept. To see this, examine figure 3C. The slope of the thickness curve trended toward a more rapid decrease in both arms of faricimab compared with aflibercept during the monthly injection stage (initial loading stage).  In an analysis of the graphs after the loading stage (monthly injections), both faricimab and aflibercept showed a similar jagged curve demonstrating a drop-off of treatment effect during the no-treatment month. A jagged response is not seen in the FPTI group because the treatment intervals varied within that group.  The zig-zag rebound of edema seen in both faricimab (F8) and aflibercept (A8) groups suggests the durability of the treatment effect may be similar between the two drugs.  These studies did not perform a direct comparison of faricimab and aflibercept on the same personalized treatment interval protocol.

The authors’ contention that faricimab rendered a higher proportion of eyes free of CI-DME is warranted by the data they present.

Finally, the authors emphasize the potential of faricimab for lesser burden of treatment because of potential longer durability. This emphasis is unsupported by the evidence presented. The F8 group received 10 injections. The A8 group received 9 injections – hence no decreased burden favoring faricimab over aflibercept in this comparison. It is more complicated to analyze in the FPTI group because the needed information is not reported, but we can make some inferences. There were 63 eyes of 286 (22%) in Yosemite and 66 eyes of 308 (21%) in Rhine that achieved the opportunity to extend treatment; these eyes underwent a total of 8 faricimab injections at week 52.  This number represents the least number of scheduled injections and only one less than the aflibercept group. The remainder of eyes were scheduled to have more than 8 injections, but the pooled average is difficult to parse from figure 3B.  We can easily note that from the figure that the greatest number of injections at week 52 in this arm of the study was 14 injections in eyes that required monthly treatment (19 eyes (7%) in Yosemite, and 22 eyes (7%) in Rhine).  This is far more than the 9 injections of A8, and does not demonstrate a reduced treatment burden among eyes in the faricimab group compared with aflibercept. When the remainder of eyes between the extremes of figure 3B are added in to the calculation of average treatment burden, which we encourage the authors to report, we suspect that it was greater for the FPTI arm of the study than for A8, not less.  

In summary, YOSEMITE and RHINE provide data that faricimab as administered in the studies was equivalent to aflibercept in the primary visual outcome, and superior to aflibercept as given in the study in drying the macula. No data were presented supporting a claim that treatment burden is less with faricimab than aflibercept. The published data show that a proportion of eyes can be managed with a reduced injection burden with faricimab, but provide no evidence that this would differentiate faricimab from aflibercept were aflibercept plugged into the same personal treatment interval algorithm. There was no arm of the study that would allow such a comparison to be made. The published data substantiate that faricimab has a greater macular drying effect than aflibercept, but the see-saw central subfield thickness curve in the non-loading phase of the first year suggests that the duration of drying by faricimab is no greater than with aflibercept.

The FDA has approved faricimab for the treatment of CI-DME based on YOSEMITE and RHINE. Retinal specialists will be making choices of which drug to use. An economic perspective will enter into the decision. The clinical decision will not be based exclusively on efficacy. The offered average costs for aflibercept and faricimab to the editorialists are $1747 and $2168, respectively. Is the $441 differential cost a reasonable price to pay for the documented differences in drug performance? Our opinion is no. There is no published difference in visual outcomes, nor any published difference in durability, because it wasn’t checked. There is a difference in macular drying, analogous to the superior drying effect of aflibercept over bevacizumab in the better-vision group of protocol T (eyes with CI-DME)or in the aflibercept versus bevacizumab group in SCORE-2 (eyes with central retinal vein occlusion with macular edema).4,5 We, and many others, did not think that differences warranted the use of aflibercept over the less expensive bevacizumab in cases similar to those in the better seeing group of protocol T or eyes like those studied in SCORE-2, nor do we think that drying difference seen in YOSEMITE and RHINE between faricimab and aflibercept is reason to choose the more expensive drug. We congratulate the authors of these studies for providing ophthalmologists with new options for treating diabetic macular edema, but nothing they have published suggests that this option marks a milestone in reducing treatment burden in DME. The 2-year results will be more informative for decision-making than the 1-year results, and we encourage the authors to remedy the flaws in their year -1 results data presentation so that the 2-year data are more useful.

By David J. Browning, MD, PhD and Scott E. Pautler, MD

References

   1.   Kiss S, Liu Y, Brown J, et al. Clinical utilization of anti-vascular endothelial growth-factor agents and patient monitoring in retinal vein occlusion and diabetic macular edema. Clin Ophthalmol 2014;8:1611-1621.

   2.   Wykoff CC, Abreu F, Adamis AP, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet 2022;DOI:https://doi.org/10.1016/S0140-6736(22)00018-6.

   3.   Demla S, Shinn E, Ottwell R, Arthur W, Khattab M, Hartwell M, Wright DN, Vassar M. Evaluaton of “spin” in the abstracts of systematic reviews and meta-analyses focused on cataract therapies. Am J Ophthalmol 2021;228:47-57.

   4.   Diabetic Retinopathy Clinical Research Network, Welss JA, Glassman AR, Ayala AR, Jampol LM, Aiello LP, Antoszyk AN, Arnold-Bush AN, Baker CW, Bressler NM, Browning DJ, Elman MJ, Ferris FJ, Friedman SJ, Melia M, Pieramici D, Sun JK, Beck RW. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med 2015;372:1193-1203.

   5.   Scott IU, VanVeldhuisen PC, Ip MS, et al, SCORE2 Investigator group. Effect of bevacizumab vs aflibercept on visual acuity among patients with macular edema due to central retinal vein occlusion: the SCORE2 randomized clinical trial. JAMA 2017;317:2072-2087.

Vuity Eye Drops for Near Vision

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Eye Anatomy. Image courtesy of Caitlin Albritton.

What is Vuity?

Vuity is a new eye drop to improve near vision in mature adults and is available with a prescription. It became available with FDA approval in 2021.  The generic name for Vuity is pilocarpine, a drug used for years to treat some types of glaucoma.  

How does Vuity work?

Vuity works by causing the pupil to constrict.  The pupil is the small black opening in the center of the iris (the colored part of the eye, usually blue or brown).  When the pupil constricts it provides a greater depth of field just like a camera with a small aperture.  Vuity also constricts the ciliary muscle inside the eye.  This is the muscle that normally focuses the eye from distance to near. 

What did the studies of Vuity show?

Gemini I and II were studies to prove the benefit of Vuity.  Between the two studies a total of 375 patients were treated.  One hour after instilling Vuity, about 26% more patients on Vuity had an improvement in near vision (three lines on the eye chart) compared with patients given a placebo.  This suggests that a majority of patients may experience less of an effect.  Vuity likely provides a modest short-term effect with minimal risk to most people making it of marginal value (cost/benefit ratio).     

How do you use Vuity?

Apply a drop of Vuity to each eye in the morning. The drop takes affect within an hour and slowly loses its effect over 6-10 hours. If Vuity is used more than once a day, it is more likely to cause side effects.   

What are the adverse effects of Vuity?

Vuity should not be used by anyone with an allergy to pilocarpine.  It should also be avoided in people prone to iritis.  Some patients notice poor vision at night while using Vuity; this is especially true if it is used after noon or in eyes with cataract.  Therefore, caution may be needed while driving at night.  Sometimes, patients experience accommodative spasm in which they have trouble focusing from near to distance.  A brow ache may occur when the drop is started, but usually subsides over time with continued use of Vuity.  Little is known about the safety of Vuity in pregnancy and during breast feeding.  If you use soft contact lenses, they should be removed before instilling Vuity.  They may be placed back in the eye after 10 minutes.  Use Vuity at least 5 minutes apart from other eye drops you use for other conditions.  Very rare adverse effects from Vuity may include acute angle-closure glaucoma and retinal detachment.  Therefore, the following symptoms should be reported promptly: new flashes and/or floaters, any loss of vision (including loss of side vision), pain, or significant redness.  

By Scott E Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

Copyright  © 2021-2022 Designs Unlimited of Florida.  All Rights Reserved. 

Tea Tree Oil for the Eyelid

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What is tea tree oil and how is it helpful?

Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree, Melaleuca alternifolia.  Tea tree oil has important anti-inflammatory and anti-microbial properties.  It is effective against many different micro-organisms that can infect the eye (see reference).    

How does tea tree oil improve the health of the eyelid?

Tea tree oil appears to help prevent the overgrowth of germs on the eyelid, which leads to blepharitis.  Blepharitis is a common eyelid condition that causes symptoms of redness, irritation, itching, burning, and dry-eye symptoms.  There are many ways to treat blepharitis and tea tree oil is becoming an important tool to reduce inflammation and infection by bacteria, fungi, and mites.  

What evidence is there that tea tree oil works?
Tea tree oil has been studied in the treatment of blepharitis with very positive reports.  However, high-level scientific evidence is lacking (see reference).  I suspect the reason for this lack of evidence is the high cost of the studies rather than the effectiveness of tea tree oil.  It takes large sums of money to complete the scientific trials required by the FDA and there is no corporate financial incentive to fund a large, randomized trial.  In the meantime, low-cost tea tree oil is available for use without a prescription.

What preparations are available?

Tea tree is available as moist lid wipes, drops, and cleansing washes (see tables below).  Follow the directions on each formulation.  To keep the tea tree oil fresh, effective, and safe, store it in a cool, dark place (drawer or cupboard) with the lid securely attached.   

What side-effects may occur?

Sometimes, a sensitivity reaction may occur with tea tree oil.  Stop using tea tree oil, if your skin or eyes develop pain, redness, and/or itching.  See an ophthalmologist as soon as possible for evaluation.  Sensitivity reactions may occur more commonly with older, out-of-date tea tree oil, as well as with products with higher-concentrations of tea tree oil.

What brands are available?

The tables below serve as a reference list primarily for cost comparison.  The various products have not been compared in a clinical study.  Some contain ingredients in addition to tree tea oil.  Review the product information, especially if you have known sensitivities.  If you wear lash extensions, the oil in some of these products (including tea tree oil itself) may loosen the attachment of the extensions.  Lash extensions are not recommended for patients with significant blepharitis.

Tea Tree Oil Products for Blepharitis
(Listed in order of least to most expensive per unit application)
Names of Lid Wipes concen-
tration		price as of (4-2021)price/wipeapplication
Dr Fischer Eyelid Wipesunknown $15.95  $   0.53 wipes 
Premium Eyelid Wipesunknown $22.95  $   0.77 wipes
MediViz  Eyelid Wipesunknown $24.97  $   0.83 wipes
Optase Lid Wipesunknown $18.95  $   0.95 wipes
Cliradex Eyelid Wipesunknown $39.42  $   1.64 wipes
Names of Cleansersconcentrationprice (4-2021)price/ounceapplication
Gentle Formula cleanser1% $     15.00  $     8.88 pump spray
Ocusoft Demodex cleanserunknown $     18.17  $   10.75 foam wash
Eye Eco Adv Formula2% $     20.00  $   11.83 pump spray
Heyedrate Foaming wash<1% $     19.97  $   11.95 foam wash
Cliradex Foamunknown $     29.99  $   19.99 foam cleanser
We Love Eyesunknown $     24.00  $   24.00 drops for Qtip
Check current prices via the links provided. This blog is supported by its readers and may earn commissions which do not increase the price to you and do not affect the content of this review article.

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

Copyright  © 2021 Designs Unlimited of Florida.  All Rights Reserved.

COVID-19 and Facial Fillers

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How can COVID-19 affect cosmetic fillers?

            COVID-19 infection or COVID-19 vaccines may cause cosmetic facial fillers to swell.  The swelling may occur hours to a few weeks after exposure.  Fortunately, this appears to be a rare adverse effect.  The true frequency is not known because it represents a fairly minor reaction among the spectrum of symptoms of COVID-19.    

What causes the swelling to occur?

            Not much is known about this uncommon reaction.  It is suspected to be due to an immune reaction to the spike protein on the virus surface.  It does not appear to be due to direct infection of the COVID-19 virus in the filler material itself.   

How long does the swelling last?

            The duration of swelling varies.  Usually, the swelling lasts only a few days, but it may wax and wane over several weeks.  Treatment may make the swelling go away more rapidly.  Fortunately, swelling of facial fillers does not appear to be a permanent problem.     

What treatment is available?

            Many different treatments have been used.  The effectiveness of treatment is difficult to assess because of the rarity of the problem.  Local treatment may include cold compresses.  Oral antihistamines have not been universally effective.  Anti-inflammatory medications such as prednisone may help; however, there is some concern about the potential interference in developing protective immunity.  Of interest, lisinopril (commonly used to treat high blood pressure) may be useful to resolve the swelling.  More knowledge will come with experience. 

By Scott E. Pautler, MD 

Copyright © 2021 Designs Unlimited of Florida. All Rights Reserved.

Anatomy of the Eye

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Anatomy of the human eye. Image courtesy of Caitlin Albritton.

The eye is a specialized organ to provide sight.  The various parts of the eye work to assist in this process.  There are two eyes per human (many more if you are a spider or a scallop).  The paired human eyes allow for improved depth perception.  It takes two eyes for a human to best determine how far an object lies in front of him or her.  Each eye has a slightly different view and the difference between the two images is used by the brain to make a three-dimensional (3-D) image.  Test: you can see the difference in depth perception by trying to thread a needle or perform a similar fine task with one eye compared with two eyes. If the two eyes are not lined up straight, a person sees two images (double vision).

Shape of the eye

The shape of the eye is fairly round like a ball.  This design helps the eye determine what direction light is coming from (see video: evolution of the eye).  In near-sighted eyes, the eye becomes somewhat elongated (like an egg).  This appears to be due to an adaptive response of the eye to aid in focusing at near.  However, the elongation of the eye causes the tissues to stretch and this predisposes the eye to retinal detachment.

The Tear Film

This is an often-overlooked part of the eye.  The tears form a smooth surface over the front of the cornea and help avoid scattering of light as it enters the eye.  The tear film also provides nutrition, protection (antibacterial), and cleansing of the surface of the eye.  The tear film is composed of three parts/layers: the aqueous (water), mucin, and lipid layers.  The aqueous component is produced by lacrimal glands that rest in the eye socket behind a bone under the eye brow.  The mucin layer is produced by specialized cells (goblet cells) in the conjunctiva.  The mucin mixes with the aqueous layer and adds structure to the tears helping them to remain on the eye surface.  The lipid layer (outer surface) produced by meibomian glands along the edge of the eye lids. The lipid helps protect against evaporation of the tears from the surface of the eye.  Various conditions and diseases interfere with one or more layers of the tear film leading to dry eyes and reduced vision.

The Conjunctiva

The conjunctiva (not labelled on image) is a smooth moveable outer “skin” overlying the white sclera (see below).  The conjunctiva acts as a physical barrier against entry of infectious organisms, and contains many blood vessels which dilate and become inflamed if infection or foreign objects threaten to damage the eye.  The smooth surface of the conjunctiva and loose attachment to the underlying sclera helps the eye turn smoothly.

The Sclera

The sclera is the tough outer coat of the eye.  It provides structural support and protection of the sensitive tissues (like the retina) inside the eye.  The sclera does allow for the outflow of water that is produced by the ciliary body.  It also allows medications to pass into the eye.  Nerves and blood vessels penetrate the sclera to reach the inside of the eye.

The Cornea

The cornea is the clear window at the front of the eyeball that allows light to enter the eye.  It is continuous with the sclera.  Most of the focusing of light happens at the corneal surface/tear film.  As this outer layer of the eye is so critical for sight, there are many nerve endings in the cornea making it the most sensitive part of the eye to touch.  The outer-most layer is the epithelium: a smooth surface to transmit light with tightly layered cells difficult for infections to penetrate.  The epithelium acts as a barrier to keep the water-filled tears from entering the cornea as this would make the cornea lose its clarity.  The middle layer of the cornea is called the stroma.  It occupies most of the cornea with orderly layers of protein fibers to transmit light and minimize scattering.  There is very little water in the stroma because the inner-most layer of the cornea (the endothelium) pumps out water from the cornea into the eye.  When the cornea becomes hazy or opaque, a corneal transplant may be performed.

The Iris and Pupil

The iris is responsible for the color of the eye as seen from the outside.  A circular opening in the iris is called the pupil, which is seen as a black spot in the center of the iris.  Iris muscles expand and contract to change the size of the pupil and alters the amount of light entering the eye.  In bright light, the pupil constricts so as to prevent too much light from entering the eye.  There is no specific function of iris color and iridology is not a true science.  However, lighter-colored irises (irides) may not block as much light as dark irides.  From a medical perspective, eyes with lighter color eyes may be at higher risk of developing macular degeneration.  Darker eyes are seen among people who evolved nearer the equator.  In birds, iris color appears to play a role in the mating ritual.

The lens

The lens inside the eye is made of specialized crystalline protein fibers that help to focus light and allow for flexibility of the lens in order to focus light from different distances from the eye.  With age the eye loses its ability to focus light; therefore, reading glasses are needed by most people around the age of 40 years.  When the clear lens turns foggy, the lens is called a cataract.  Surgery may be performed to remove a cataract and replace it with a clear plastic lens implant.  

The ciliary body (SILL-ee-air-ee)

The ciliary body has two functions inside the eye.  It contains muscles to focus the lens (the ciliary muscles are attached to the lens by fine fibers called zonules).  The ciliary body also has a pump that produces aqueous (water).  The aqueous pump works to keep the eye inflated.  The aqueous also provides nutrition to the structures inside the eye.  There is a constant flow of aqueous into the eye via the ciliary body and out of the eye through the sclera (i.e. the trabeculum).  If the trabecular drain becomes blocked, the pressure in the eye goes up and damage may occur to the optic nerve.  This condition is called glaucoma.

The Vitreous

The vitreous is a clear gel that fills most of the eye.  There are no blood vessels and very few cells in the vitreous.  The clarity of the vitreous is important in order to allow light to pass from the lens to reach the retina.  The vitreous is mainly composed of water, but there are fine protein fibers and a gel (hyaluronin) providing a unique structure.  If the eye becomes cut from an accidental trauma, the vitreous gel may plug the hole in the sclera keeping the eye from deflating.  The vitreous also appears to protect the lens; there are anti-oxidants in the vitreous gel that help keep the lens clear.  

With age, the vitreous loses its gel-like quality and the protein fibers begin to clump together.  When this happens, fiber-like floaters may appear in the vision.  These floaters occur earlier in life in near-sighted eyes and in eyes following inflammation or trauma. Occasionally, the vitreous fibers will pull on the retina causing brief, streak-like flashes of light in the vision.  The pulling may cause a retinal break (retinal tear), which may lead to retinal detachment.  In other situations, the vitreous fibers may pull on the macula resulting in distortion of vision from vitreo-macular traction syndrome, epiretinal membrane, or macular hole.     

The Retina

The retina is a light-sensitive layer of nerve tissue that lines the inside of the eye wall.  It acts like the film in a camera.  The central portion of the retina is called the macula.  The macula is designed for central vision.  When you read or see fine details, you move your eye so that light focuses on the macula.  The rest of the retina is used for peripheral vision (side-vision).  The peripheral vision is essential for walking around a room without bumping into things.  The peripheral retina is also sensitive to detect movement in the environment.  The blood supply to the inner retinal layers (ten layers in all) comes from retinal blood vessels that enter and exit the eye through the optic nerve.  The outer retinal layers are supplies by blood vessels in the choroid (see below).  Blockage of the blood supply (retinal artery occlusion or retinal vein occlusion) causes a blind spot in the vision or blurred vision.  If the retina becomes detached from the eye wall, it does not function well, and surgery is required to recover vision.  Aging may result in macular degeneration. 

The Choroid

The choroid is a layer of tissue under the retina filled with blood vessels.  This important blood vessel layer provides oxygen and nutrition to the retina.  It also evacuates waste materials from the outer retina and acts as a heat sump, keeping the retina from overheating.  The choroid may be affected by a number of problems including inflammation, blood vessel blockage, and central serous retinopathy.   

The Optic Nerve

The optic nerve connects the nerve tissue of the retina to the nerve tissue in the brain, like wire in an electric circuit.  The optic nerve is sensitive to the pressure inside the eye.  High intra-ocular pressure may cause loss of vision or blindness from glaucoma.  The optic nerve may also be affected by blocked blood flow, inflammation, and pressure from outside the eye (tumors and aneurysms).  

By Scott E. Pautler, MD

Copyright © 2021 Designs Unlimited of Florida.  All Rights Reserved.

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.