An estimated 19.8 million Americans over the age of 40 have a diagnosis of macular degeneration (AMD), which can cause significant central vision loss as the disease progresses from year to year. Genetics, lifestyle, and diet are all major risk contributors, but the older we live, the aging process also plays a significant role in our increased risk of AMD. By age 80, 30% of Americans have macular degeneration. A number of treatments have changed the way we manage macular degeneration and preserve the vision of those affected. Anti-VEGF treatments for wet macular degeneration are the standard of care to preserve and in some cases even improve vision. Dry macular degeneration has been historically without treatment, but in 2023 the FDA approved two treatments for the most severe form of dry AMD, geographic atrophy, which can slow the worsening of this condition but did not show any vision improvement. So for the the majority of patients with AMD (90% of Americans have the dry form of the disease), there has been no treatment that could improve or restore any vision that person had lost.

Until now.

On November 5, 2024, the FDA approved the Valeda Light Delivery System as the first ever treatment for vision improvement in patients with dry AMD. The treatment is for patients in the early stages of dry AMD that have no progressed to geographic atrophy. The device uses photobiomodulation, a treatment currently used in arthritis, wound repair, physiotherapy and sports medicine, which targets the mitochondria at the cellular level to stabilize metabolic cellular function. In AMD, the macular photoreceptor cells are struggling to metabolize light energy and free radical damage, resulting in the build up of waste and debris (drusen) at the macula, inflammation, and is the condition advances, scar tissue (geographic atrophy) and bleeding inside the eye (wet macular degeneration). By targeting the mitochondria of macular photoreceptor cells to increase metabolism, increase ATP (energy!) production, and boost cellular repair in response to light and free radical damage, tissue function is better preserved and protected. Using this photobiomodulation approach, the Phase III LIGHTSITE trial showed that patients gained an average of 5 letters of improvement in vision over a 2 year period using the device. Let's break down the data from this pivotal study:

The LIGHTSITE III trial was a double-masked, sham controlled, multi-center study that was run at 11 eyecare centers across the United States and included 100 patients (148 eyes) with early or intermediate stage dry AMD. Included study participants were age 50 or older (average age was 74.4), and have best corrected vision of 20/100 to 20/32 Snellen Acuity. Patients with geographic atrophy or wet AMD were not included in this study. If a patient had significant cataract that would affect vision or would require surgery in the next 2 years, or a history of other eye conditions or diseases that can affect vision including glaucoma, retinal vascular diseases, macular edema, amblyopia (lazy eye), or nystagmus), they were also excluded. Because the treatment is light-based, any patients that had light sensitivity disorders (including history of seizure, epilepsy, or migraine) or that were taking photosensitizing medications could not participate.

The Valeda device is an in office treatment that stimulates improvement in cellular metabolism. Currently available in Europe and South America, this device is now FDA approved and will be available in the USA at eye doctor in the near future. via

Treatment: Subjects were given in office treatments with the Valeda device using photobiomodulation at 3 wavelengths: 590 (yellow), 660 (red), and 850 nanometers (near infra-red), or a Sham treatment that emitted much less light (the sham mode delivered 50x less 590 nm, 100x less 660 nm wavelengths and no 850 nm wavelengths).  Participants received these treatments over 9 sessions spaced over 3-5 weeks every 4 months for a period of 24 months. 

Results: At 13 months the Valeda-device treatment group had a statistically significant improvement in gained visual acuity over the sham treatment group. At month 13 patients had received 4 series of treatment, and the average change from baseline in best corrected vision was +5.4 letters in the treatment group, versus +3 letters in the sham group. Over half (55.5%) of patients in the treatment group increased vision by more than 5 letters: 26.4% of the treatment group had 10 or more letter gain, and 5.5% had a 15 or more letter gain in best corrected vision. At 24 months, these results were sustained, with an average improvement of 5.9 letters from baseline in the treatment group.

In addition to an improvement in best corrected vision, the treatment group also showed a reduced risk of vision loss over the study period. Only 7% of treated eyes lost more than 5 letters during the 24 months of the study, versus 18% of the sham treatment group who lost more than 5 letters of best corrected visual acuity. 

Also, significantly fewer of the Valeda device treatment group went on to develop geographic atrophy over the 24 month study. 6.8% of the treatment group developed geographic atrophy versus 24% of the sham group. 

The device was well tolerated with 3 participants having device-related adverse events- all of which were dry eye in nature. 5 of the study participants with treatment went on to develop wet AMD versus only 1 of the sham group, but these results were not deemed to be statistically significant on review (treatment versus sham group enrollment was 2:1). 

Stay Tuned: Now that this device is FDA approved, the developer LumiThera will need time to ramp up production and develop access channels. You can sign up on their website to get updates about device availability. They also have a Valeda locator on their website (but right now no offices in the United States are listed). 

With cataract surgery the most commonly performed surgical procedure in the United States (an estimated 3.5 million surgeries are done each year by ophthalmologists in the US!), optometrists take on the majority of post-operative care needs for these patients. Typically the ophthalmologist who performed surgery sees the patient for a 1 day post-op visit, and then releases care to a partnering optometrist for the 1 week and subsequent follow-up visits over the 90 day post-operative period. Optometrists are trained and skilled at handling post-operative care and complications, but handling the billing and coding for post-operative care poses unique challenges because insurances require that the doctor split reimbursements with the surgeon who performs the surgery and who who initiates the post-op care on day 1. If you need a quick reference on filling out insurance claims for post-operative cataract surgery care, this guide is for you!

When you see the patient for their initial post-op visit under your care, you will file CPT code 66984-EXTRACAPSULAR CATARACT REMOVAL WITH INSERTION OF INTRAOCULAR LENS

• Link this code to the cataract in the eye that just had surgery. Yes, I know there is no cataract now during your post-op care because surgery was done to remove it. But your post-op care is getting partial payment from insurance for the overall procedure, so you're linking it to the cataract that used to be there. It is important that you use the same cataract code that the operating surgeon did. If the codes don't match, insurance will reject. Most surgeons use H25.81X Combined Forms of Age-Related Cataract, but make sure you match what was used in the transfer of care document sent by the surgeon.
• use modifier -55 Post-Operative Management
• use modifier -LT or -RT pending which eye was operated on (and make sure you've linked that to the appropriate cataract code H25.811 for right eye, H25.812 for left eye)
• use modifier -79 if you are initiating post-operative care for the second eye during the global period of the first eye's cataract surgery post-op care

Example of a cataract post-op claim filed to BCBS. This claim was approved and paid by insurance!

Note in the additional claim information section you put the referring doctor (Box 17), initial treatment date (SURGERY DATE!), report care start date is your first day of post-op care, and report care end date is the last day of the 90 day global period. I always spell it all out in Box 19 too.

Scleral contact lenses can be a complete life-changer for those living with blurry vision, halos, and ghosting due to irregular corneas. Keratoconus, corneal transplants, corneal scars, and even severe dry eye can cause distortion to the smooth symmetric shape of a normal corneal surface, blurring and bending vision into distortion, halos, and glare. A key to scleral contact lens success (clear vision and lasting comfort!), using the right products to both fill and clean your lenses is essential. When you put your scleral lens on, you will always fill the lens up to the brim with preservative free saline.  If you put the lens in dry, you will have a massive air bubble in the center of the lens, resulting in very blurry vision. Filling the lens up with saline keeps those air bubbles out of the lens for clear vision, and also keeps the cornea hydrated all day long, which is why scleral lenses can be used to treat severe dry eyes. Whatever saline you fill your lens with prior to insertion will stay there all day long until you remove the lens. Because of that long contact time with the cornea, the saline must be:

Preservative Free

Preservatives are used in multiple purpose contact lens solutions and many eye drops to help kill bacteria. But those preservatives that are toxic to bacteria are ALSO toxic to your cornea. The most common mistake I see patients making with their scleral lenses is going to a local pharmacy, grocery, or big box store and buying preserved saline like Biotrue or a store brand contact lens saline and thinking that would work. Studies show filling your scleral lens with preserved saline causes lens fogging, sloughing of the corneal epithelium (think of this like dry skin cells flaking off- but on your eye!), redness, and discomfort.  

Sloughing of dead corneal epithelial cells (called SPK or superficial punctate keratitis) is a sign of severe dryness or toxicity to the cornea. Preservatives are toxic to corneal cells, but are found in all multipurpose contact lens salines or solutions because those types of products are meant to clean your contact lenses.

Buffered or Non-Buffered

Studies have shown some scleral lens wearers may prefer buffered saline (where the pH of the saline matches the average pH of the tear film which is 7). Borate and phosphate are common buffers used in some brands of preservative free saline, with a goal that if the pH of the saline matches the pH of the tear film there should be less burning or discomfort with lens wear. In real life, the data suggests that buffered versus nonbuffered doesn't make a difference to most patients. In a 2020 study of 27 patients wearing scleral lenses for 3 months, there was no difference in corneal health or comfort for patients using buffered or non-buffered preservative free saline options. 

If you find dryness/irritation/burning with scleral lens wear, it may be worth switching from buffered to nonbuffered preservative free saline or vice versa to see if you find one to be more comfortable.

Buffered Preservative Free Saline

PuriLens saline comes in convenient reusable bottles. It can be purchased at Amazon or Walmart

ScleralFil has single use vials, which is lower risk for contamination than reusable bottles. It can be purchased at Amazon or Walmart.

Non-Buffered Saline

Lacripure saline is preservative free, buffer free, and specifically designed for scleral lenses. It can be purchased at Amazon or Walmart.

The following products are not specifically made for scleral contact lenses, but have been used successfully for filling scleral lenses for years before specific scleral products came on the market. Your doctor may also be able to write you a prescription for 0.9% NaCL inhalation vials for filling your scleral lenses, but due to manufacturing and backorder issues, it is increasingly difficult to find pharmacies that stock this product. 

AddiPak saline vials have become increasingly difficult to find. You can only purchase them on Amazon now if you are a verified healthcare provider. The limited supply is due in part to a large recall of AddiPak saline manufactured by Hudson RCL in September 2023 issued by the FDA over concerns that the vials were not sterile.

Modudose inhalation vials are still readily available on Amazon.

Electrolyte Enriched

Nutrifill is a preservative free, pH buffered saline for scleral contact lenses that also has electrolytes (calcuim, magnesium, potassium, and phosphate) meant to mimic the ionic makeup of the natural tear film. In a study of 22 patients comparing filling their scleral lenses with NutriFill versus their habitual saline that did not contain electrolytes, there was statistically significant improvement with NutrFill use in their dry eye symptoms and subjective vision clarity and stability. When visible fogging of the lens fluid was assessed via imaging by the doctor there was no statistically significant difference between the saline options, however. 

Nutrifll can be purchased at Walmart.

Talk to your doctor about what scleral lens filling solution is recommended for use for your particular lenses and your unique eye chemistry. Never use multipurpose contact lens solution to fill your lenses. As of writing this article, if you can buy it at a grocery store, Target, Walmart (on the shelf) or a pharmacy over the counter - it's not the right saline -- these products are only available to purchase online at this time because only people who wear scleral lenses would ever need these products. Read all of the ingredients carefully, and only use saline that is preservative free to avoid injury and irritation to your eyes!

Are you eagerly awaiting news of FDA approval for low dose atropine for myopia management? Several pharmaceutical companies are pursuing FDA approval and are finalizing Phase III clinical studies for review. Currently low dose atropine for myopia management is prescribed as an off-label use by doctors to slow the progression of myopia, backed by numerous international studies including the ATOM 1 and 2 and LAMP 1 and 2 studies. Currently only 1% atropine is commercially available at a pharmacy, so to get the low concentrations (0.01 to 0.05% atropine) required for effective myopia management, doctors must use compounding pharmacies. FDA approval of a commercially available low concentration atropine for myopia management would allow for easier access and wider utilization of this treatment option. Here’s what we know so far about the three commercial products currently in Phase III status: 

NVK002 (Vyluma) 

preservative free 0.01 and 0.02% atropine

The final Phase III CHAMP trial data was published in October 2023, including international data of over 500 children and 4 years of study data. The data showed statistically significant slowing of spherical equivalent and axial length growth with 0.01 and 0.02% atropine use. An FDA Prescription Drug User Fee Act (PDUFA) date was scheduled for 1/31/24 but there has been no further news as that date came and went. A PDUFA date is set typically 6-10 months after the original study data has been sent to the FDA for review, but occasionally the PDUFA date is extended if the FDA requests more data before making a determination. 

MicroPine (Eyenovia) 

0.01% and 0.02% in the microdose Optejet dispenser

The Optejet dispense makes it easier to insert eye drops, sending a gentle spray of drop directly onto the eye without having to hold the eye open.

Phase III CHAPERONE study began enrolling patients in 2019 and has an expected end date of June 2028. In a press release from  January 2024, Eyenovia plans to “accelerate and engage the FDA on expediting development” after a slight slowdown as Eyenovia and Bausch and Lomb worked out licensing agreements. 

Eyenovia's patented Optejet Dispenser via

SYD-101 (Sydnexis)

0.01% and 0.03% atropine with a pH stabilizing agent

A pH stabilizing agent would help reduce the risk of stinging with drop insertion

Phase III STAR study is ongoing and not yet published. Estimated completion is 2025 with an early read out expected in May 2024 per the company's website. 

What about FDA approval of myopia management glasses? 

Currently FDA approved myopia management is only available with contact lens options, so for patients or parents who want to slow the progression of their child's prescription changes, but aren't ready for contact lenses, there is nothing available to them with FDA approval. In addition to FDA approval of low dose atropine, myopia management glasses are also pending with the FDA. In February 2024 the FDA granted "Breakthrough Device Designation" to SightGlass Vision's Diffusion Optics Technology (DOT) myopia management glasses. This designation means the FDA is "fast-tracking" the review and approval process to bring this device to market. If approved by the FDA, this would be the first myopia management glasses option available in the US (currently they are already available in Europe, Asia, and Canada). 

SightGlass Vision DOT myopia management glasses are being fast-tracked for approval by the FDA via

Whether your patient has keratoconus, pellucid marginal degeneration, or irregular cornea post-corneal graft surgery, standard contact lens solutions are likely not going to provide the best vision. While scleral lenses have become a go-to for irregular corneas over the past decade, some patients struggle with insertion and removal of a larger lens, and a smaller RGP option is more ideal for them. Luckily the ROSE K family of RGP lenses gives us a range of options and is available from a number of different specialty contact lens manufacturers across multiple countries. 

I highly encourage you to visit the ROSE K practitioner website for in depth fitting guides, FAQs, and even videos. But if you are looking for a quick beginner's reference guide for getting started with this lens, this post is for you!

ROSE K lens selection

For each type of irregular cornea, well there's a Rose K lens for that. Each fit set has different fitting protocols for selecting initial lens base curve, so the first important step to a good Rose K fit is to choose the right fit set for your patient. 

Rose K2 KC: for keratoconus patients and more oval cones - most of your keratoconus fits (around 70%) will use this lens

Rose K2 NC: for keratoconus patients with very central "nipple" cones. This is where the center of the cone is within 1 mm of the visual axis

Rose K2 PG: for post-graft patients with more oblate corneas

Rose K2 IC: for more diffuse irregular corneas like pellucid marginal degeneration patients

Rose K2 XL: a corneoscleral lens for larger diameter irregularities

Rose K2 Oblate XL: a corneoscleral lens for larger diameter irregularities post-surgical oblate corneas

Most of the irregular corneas a practitioner will be fitting are keratoconus patients, and most keratoconus patients would fall under the Rose K2 KC lens so that's likely the fit set you'll use most. I say this as a practitioner that only has the Rose K2 IC fit set and have wondered why the base curve fitting guide always seems to be wrong for me - after further education I know now it's because I was trying to fit a lens design that wasn't made for this specific patient group. Don't make my mistake - use the right fit set for the right patient category.

via

ROSE K FUNDAMENTALS OF A GOOD FIT

There are 5 steps to a good Rose K fit - after you've selected the right fit set for the patient you have in front of you of course.

1. Central Fit - base curve selection

Follow the fit guide for how to convert your patients K readings to initial diagnostic lens selection. Place the lens on eye and instill NaFL dye to assess the pattern. You only need to wait a minute or so for settling - the lens will reveal how it fits very quickly. Judge the fit relationship immediately after a blink. Look for a "light feather touch" over the steepest apex of the cornea. What is a light feather touch? If you go just 0.1 mm steeper, then you'll get no touch. Bracketing the fit steeper and flatter until you find that point of just barely touch is ideal.

What happens if you fit a lens too flat (with more than a "light feather touch")? If the lens is rubbing on the cornea you can create punctate keratitis or even scarring issues. The lens will be uncomfortable or even painful to wear. 

If you fit a lens too steep (too far off the cornea) you will get vision issues with halos, ghosting, and fluctuating vision. You can even have "dimple veiling" on the cornea where bubbles under the too-steep lens cause distortion to the corneal surface. 

Both too flat and too steep cause problems, so it's important to spend extra time getting that initial base curve selection nailed down by bracketing until you find the most ideal lens fit where just 1 step steeper is too steep.

A "light feather touch" over the apex of the cone is ideal. via

this fit is too flat - need to increase the base curve! via

2. Peripheral Fit - edge selection

All of the diagnostic lenses in your fit set come with a standard edge lift. When evaluating the lens edge focus on the 3 + 9 o'clock position because that is usually the flattest meridian of the cornea. Ideally you should see 0.6-0.8 mm band of NaFL dye at the edge.  If the edge is too tight (barely any NaFL dye) then increase the edge lift to flatten the periphery. If the edge is too loose (excessive NaFL dye) then decrease the edge lift to steepen the periphery. A loose edge your patient will tell you how uncomfortable it is!

3. Overall Diameter

Per fitting gurus you want "the smallest diameter needed for good centration and movement". The larger the irregularity of the cornea, the larger your diameter will need to be. A central nipple cone patient will need a smaller diameter lens; a patient with pellucid where the irregularity is really far from the visual axis will need a larger diameter lens. 

Your diagnostic lens set comes in specific diameter ranges for each type. So for example the Rose K NC has much smaller diameter than the Rose K PG where the irregularity would be more peripheral. This takes us back to the original point where you need to pick the right Rose K fit set for the type of patient you are fitting. 

4. Location - is the lens centered?

You can adjust lens centration by adjusting 1) edge lift, 2) base curve, and 3) diameter. Make adjustments in that order until each element is maximized to ideal fit relation as outlined above. 

If a lens is riding high:

• Decrease the edge lift
• Steepen the base curve
• Decrease the diameter

If a lens is riding low:

• Increase the edge lift
• Flatten the base curve
• Increase the diameter

This is a really great lens to troubleshoot. Obviously it is riding low. At first glance you might think there is excessive edge lift, BUT remember you should judge edge lift and 3+9.  At 3+9 you actually see there is minimal edge lift, so our initial change to fix this lens centration issue would be step 1 on the guide above: increase edge lift. via

5. Lens Movement

Movement is important for tear exchange under the lens and healthy oxygen flow to the cornea, but excessive movement can also lead to discomfort and lenses easily decentering or even falling out. Ideal lens movement is 1-2 mm with blink. Edge lift is the main element that controls movement. 

Increase edge lift to increase movement; decrease edge lift to decrease movement

If a patient tells you the lens is very hard to remove and is "tight" on the eye - that's a sign to increase the edge lift.

Check out the Rose K practitioner website for more great education! And don't forget that your reps in the consultation department are skilled at troubleshooting these lenses and can help guide you in what questions to ask yourself when designing changes to a fit.