Quick Hits

Patterns of anti-VEGF treatments suggest two stages to DME

A study of patient claims could indicate a more resistant second stage of the disease.

By Robert Stoneback, Associate Editor

Data from a new diabetic macular edema study provides further evidence that DME patients can be divided into two categories – those in a permeability stage of the disease and those in a later inflammation stage.

The study, published in Ophthalmic Surgery, Lasers & Imaging Retina, wanted to examine how patients respond to anti-VEGF injections in an actual clinical setting, as opposed to how they are treated within controlled clinical trials. To study the behavior of DME patients in a clinical setting, Pravin Dugel, MD, and his fellow researchers examined the Medicare Standard Analytic Files provided by the Centers for Medicare and Medicaid Services. Data from 772 patients were studied. All the patients were diagnosed with DME between 2008 and 2010, and received an anti-VEGF treatment for DME.

Permeability and inflammation

Perhaps the most important point of the study, according to Dr. Dugel, is that there could be two types of DME patients. In the study, the first group responded well to anti-VEGF injections during an earlier permeability stage, which is defined by blood vessel leakages. The second group needed additional treatments once the ailments progressed to an inflammation stage. The information culled from the database analysis reflects the findings of previous studies, which also support this theory, says Dr. Dugel.

While doctors don’t yet have an effective way to determine if a patient is in one stage of DME or another, Dr. Dugel says this research shows anti-VEGF injections are likely only helpful during the permeability stage.

The supporting data from Dr. Dugel’s study show 46% of patients who had multiple visits for DME had their final visit for DME during the first year of their diagnosis. The rest, 54%, had their final DME visit during the second or third year studied.

Diagnostic patterns

Once DME advances to the inflammation stage, anti-VEGF alone is insufficient. Based on research separate from this study, Dr. Dugel says that the only other approved treatment for DME are steroid delivery devices, which can reduce inflammation.

In Dr. Dugel’s DME study, 65% of patients received their final anti-VEGF treatment for DME within a year of diagnosis, while the remaining 35% continued to receive those treatments throughout the study. Patients who received their final DME diagnosis in year one submitted a mean of 1.9 anti-VEGF claims, while those receiving final diagnosis in year two or three submitted a mean of 4 and 7.2 claims, respectively.

Among the 772 patients, 19% submitted intravitreal triamcinolone acetonide claims and 34% submitted laser treatment claims. These were made in addition to the anti-VEGF claims.

While the study can’t say for certain that the halt to claims filed is a result of successful treatment for DME, it does show the behavior of those afflicted, says Dr. Dugel.

“There seems to be a bimodal patient population,” he adds.

New trial models

This study also shows that the model used for clinical trials may not be sustainable.

In the first year of diagnosing a chronic disease such as DME, the patient should be treated every month or so, according to Dr. Dugel. Actual patients, though, go to clinics far less often. DME patients usually only go to clinic for injections three to four times a year, says Dr. Dugel.

The treatment burden is not the injections themselves, but in patients being able to adjust their work and social schedules around visiting a clinic, making the number of injections an inaccurate proxy for treatments, Dr. Dugel explains.

“In real life, people just aren’t getting (the injections),” he adds. OM

Older Latino? AMD patient? Beware of those QOL dips

A new study finds the disease can cause greater quality-of-life damage at early stages.

By Robert Stoneback, Associate Editor

Older Latinos with AMD face a substantial decline in quality-of-life even in the early stages of the disease, according to a new study by the University of Southern California Roski Eye Institute.

Published in JAMA Ophthalmology in May, the study is the first to analyze risk and prevalence of early and late stage AMD and its impact on quality of life for older Latinos.

The study examined 4,876 Latinos in the Los Angeles area, and found those diagnosed with bilateral AMD with large drusen and depigmentation, as well as more severe AMD, had substantially lower health-related quality of life compared to those with AMD lesions in only one eye.

“The study results are a wake-up call for both ophthalmologists and those in the Latino community to avoid a quality of life decline due to ocular conditions, especially in earlier stages of eye diseases such as AMD,” said Rohit Varma, MD, MPH, interim dean of the Keck School of Medicine of USC and director of the USC Roski Eye Institute, in a release from the institute. Those with early AMD affecting both eyes are especially vulnerable quality of life declines, and may benefit from referrals to low vision specialists, he said.

Among the statistics listed were:

• 80% of early-stage AMD participants reported difficulty driving, vs. 43% who had late-stage AMD

• 91.6% of early-stage AMD participants had vision-related social function impact, vs. 67.7% with late-stage AMD

• 74.4% with early-stage AMD re-ported near vision problems, vs. 46.9% of late-stage AMD sufferers.

“This information may help Latinos better understand how AMD can impact their day-to-day activities and well-being, even in earlier stages of the disease,” wrote Dr. Varma, via e-mail. It is important for Latinos to visit ophthalmologists for regular check-ups, to catch and begin treatment for AMD as early as possible. Vitamins may also prevent early or moderate AMD from progressing.

Latinos who already have AMD should continue regular check-ups.

For ophthalmologists treating Latino patients, Dr. Varma advised using additional methods of vision evaluation, including contrast-sensitivity and depth perception. This will give a more complete understanding of a patient’s AMD and its effects. This is even more important for patients who have moderate AMD in one eye, who are at risk of a substantial decline if the other eye becomes affected. The patient’s ability to function at daily tasks should be evaluated at follow-up exams as well.

Recent advances in anti-VEGF treatment for late stage AMD have made it possible for patients to improve their visual function and quality of life by monitoring and treating the disease, said Dr. Varma. Patients with vision loss can also receive advice from a low-vision professional on how to create a safer home environment. And, physicians should advise any smokers to quit the habit, as it is a risk factor for AMD. OM

New Flying Eye Hospital takes flight this summer

The new aircraft, and crew, will continue Orbis’ mission of treatment and education.

By Robert Stoneback, Associate Editor

Theresa could not see the hospital when it landed in her home country of Zambia.

Dense cataracts had left the young girl bilaterally blind, which kept her from school and made her the target of bullies. Her life changed when the Orbis Flying Eye Hospital visited Zambia in 2012, bringing with it ophthalmologists from around the world.

The hospital is a customized plane with an ophthalmic teaching hospital built into it. Orbis has been operating the Flying Eye Hospital program for the past 34 years, and its newest model, an MD-10 aircraft, was unveiled this June in Los Angeles. The new hospital toured several cities in the U.S. during June and July, including Washington, D.C., and New York. It will be departing in September for its inaugural program to Shenyang, China.

Orbis only works in countries where it is invited, and its team works alongside regional health officials to design suitable programs.

During the two- to six-week period the hospital visits a region, the staff performs operations and provides additional education to local ophthalmologists as well. At every stop, two to three local doctors will work side by side with Orbis staff. Orbis-assisted surgeries can take place either in the aircraft or at local hospitals.

According to Orbis, over the past five years the group has facilitated 10,000 trainings of doctors and 11.6 million screenings and eye exams. In 2015, just under 66,000 eye surgeries were performed, 24,000 of those on children.

Daniel Neely, MD, ophthalmology professor at Indiana School of Medicine, is one of hundreds of Orbis Volunteer Faculty members. He recalled removing the cataract from Theresa’s right eye in 2012.

“When we removed the patch the day after surgery, she was stunned and quite emotional,” he says. “It took her a few minutes to orientate herself … I recall her looking out the plane window in awe.”

Theresa’s surgery was also overseen by a local doctor, Dr. Mboni. At the time Orbis visited, he was the only pediatric ophthalmologist in Zambia, a country of 15 million, and was largely self-taught. That’s not uncommon in low-resourced countries visited by Orbis, according to Dr. Neely.

Orbis worked with him to help build his pediatric skills, according to Dr. Neely. Orbis has continued to work with Dr. Mboni over the years, even sponsoring a “mini-fellowship” for him to work with Dr. Neely in the U.S. Dr. Mboni has since mentored other doctors in Zambia.

To more thoroughly educate ophthalmologists around the globe, the newest flying hospital model contains new technology such as 3D filming and broadcast capabilities, to better teach doctors in the plane’s classroom.

Staffing the plane is a full-time team of 22 permanent employees, including nurses, ophthalmologists, anesthetists, AV and IT specialists, flight operators, administrators and mechanics, according to Orbis. The team members come from 12 countries.

Each program is also joined by Volunteer Faculty members, usually 12 per trip, who lead training programs. Orbis’ Volunteer Faculty is comprised of more than 400 medical experts, from training hospitals and institutions around the globe, who hail from 30 countries. The plane is flown by a team of volunteer pilots from FedEx.

In a typical year, the Flying Eye Hospital will visit eight to 10 cities, a pace that will be matched by the newest model. When the hospital is not in the air, it undergoes maintenance checks while the crew works to develop and prepare upcoming programs.

The previous plane will retire to Tucson, Arizona’s Pima Air and Space Museum, according to Orbis.

Dr. Neely describes his experience with Orbis as “incredibly gratifying.”

“It teaches people to become teachers themselves,” he adds.

In Theresa’s case, that describes her as well as the doctors.

A few months after the hospital left Zambia, Dr. Mboni successfully removed the cataract from Theresa’s left eye, says Dr. Neely. Today, she is a “happy, confident young women” who dreams of being a teacher herself.

Orbis is donation-driven; they can be made at orbis.org. OM

A last word on May’s ASCRS

And OIS too: LASIK and social media, the blind use their tongue to “see” and more.

LASIK numbers up following new campaign

Abbott Medical Optics took to social media recently to reach out to those considering LASIK. The company also did its own market research.

As part of their direct-to-consumer LASIK campaign, the company wanted to determine why people undergo, consider or forego the corrective treatment. For the campaign, more than 1,200 U.S. consumers were surveyed about LASIK, according to Viru Parlikar, director of global consumer marketing for Abbott.

Using the results of the research, Abbott has engaged its target market on social media platforms such as Facebook and Tumblr, as well as other digital marketing channels. The social media campaign addresses topics such as cost, potential side effects and fear of undergoing LASIK, as well as content on hassles involving contacts and glasses, all written in a way designed to resonate with the millennial audience. The campaign also directed people to Abbott’s backinfocus.com web site, where they could find a LASIK doctor and calculate costs.

Procedure rates for LASIK have declined since the start of the recession; see The Efficient Ophthalmologist.

Study: dropless treatment more effective than traditional drops

A recent study has found that Imprimis Pharmaceuticals’ Dropless Therapy is more effective than traditional eye drops for treating cystoid macular edema (CME). Ahad Mahootchi, MD, a study investigator, presented the findings of the investigator-initiated clinical study at ASCRS.

A total of 1,200 cataract surgery patients were monitored for the report.

Imprimis Pharmaceuticals’ Tri-Moxi-Vanc formula of Dropless Therapy was used on 600 cataract surgery patients, who also used a nonsteroidal anti-inflammatory drug post-operatively. Another 600 patients used the NSAID post-operatively, along with traditional steroid drops.

The study found the CME rate in the Dropless therapy group of patients was 0.5%, and 1.5% in the group that received the post-operative steroid drops.

“We've found a combination that is undoubtedly better than what we were doing before … we have set a new bar for CME reduction by combining Tri-Moxi-Vanc with an NSAID drop,” said Dr. Mahootchi at ASCRS. “This is the most significant reduction in CME post-cataract surgery that we have seen in quite some time.”

BrainPort gives sight to blind via tongue

A vision aid for the blind is redefining the concept of sight.

The BrainPort, from Wicab Inc., is a video camera attached to a pair of sunglasses, which connects via a cable to a sensor array worn on the tongue. The tongue array contains 400 electrodes capable of “translating” nearby objects detected by the camera into a stimulation felt on the tongue. According to Wicab’s website, the sensation is described as “pictures being painted on the tongue with tiny bubbles.”

The black-and-white camera strongly stimulates the tongue upon detecting “white” objects; “gray” objects provide mild stimulation, and “black” objects give none at all. This can even be used to perceive writing on signs. A controller can adjust the stimulation level.

Wicab’s founder and CEO, Robert Beckman, spoke about the BrainPort at the Ophthalmology Innovation Summit, and showed a video of a blind man using the BrainPort to aim and throw a dart at a nearby dartboard. That video and others can be viewed at http://www.wicab.com/#!video/sk1t6.

The FDA approved the BrainPort in June 2015 as a tool to aid patients with only some or no light perception.

A study from the March-April 2016 issue the Journal of Visual Impairment & Blindness examined 57 participants who used the BrainPort for a year after completing the device’s required 10-hour training course. The study found that 91.2% of the participants could perform object recognition using the BrainPort and 57.9% could perform orientation and mobility tasks beyond chance level.

No device-related serious adverse events were reported.

Alcon “alliance” will bring IOL to U.S.

A new wave of IOLs will be brought to the market, thanks to a new partnership between Alcon and PowerVision.

The partnership, described by the two companies as a “strategic alliance,” will allow PowerVision to release its accommodating IOL, the FluidVision, to the U.S. The IOL is able to change focus through means of a fluid-driven, shape-changing technology, according to an Alcon press release. The fluid is carried in the IOL, and is transported by the eye’s natural accommodating muscles.

The lens is intended for cataract patients who also have presbyopia.

Speaking at OIS, Barry Cheskin, PowerVision’s co-founder, president and CEO, said the IOL has been implanted into 150 eyes, with no adverse effects after 36 months of study.

The FluidVision is currently an investigational device, not available for sale or use in the U.S., according to PowerVision.

Ocular insert compares favorably to drops

A topical bimatoprost ocular insert may provide an alternative to timolol eye drops for patients suffering from glaucoma or ocular hypertension, according to a recent study published in Ophthalmology.

James D. Brandt, MD, one of the paper’s researchers, presented the study findings at OIS.

The insert, a band placed around the eye and under the eyelids, is designed to decrease IOP by regularly releasing bimatoprost into the eye for up to six months; this would eliminate the need for doctors to instill their own drops.

The test compared 130 adults with either open-angle glaucoma or ocular hypertension. They were split into two groups, one of which received the insert and artificial tears twice daily, and another group that received a placebo insert plus timolol drops twice daily.

After six months of observation, a “clinically relevant reduction in mean IOP” was noted in the group receiving the insert. A mean reduction from baseline IOP of -3.2 to -6.4 mmHg was observed for the bimatoprost group, compared to -4.2 to -6.4 mmHg for the timolol group, according to the researchers.

The study noted that the insert appeared to be safe and well tolerated by those who had it implanted.

I-OPS aims to streamline surgeries

Reliance Medical Products and Haag-Streit USA want to streamline the operating room with their In-Office Procedure System.

The I-OPS, which launched this past May, comprises a metal tray and adjustable arm that can attach to an operating stand. The tray has customizable inserts that physicians can use to securely place up to nine objects on the tray. The I-OPS comes with two syringe holders, deep and shallow cups and one each of a dropper bottle holder, twist bottle holder and gel pack holder. Additional inserts are available for purchase.

The I-OPS allows physicians to have their tools at hand without the need of an assistant or the need to turn around and reach for supplies.

According to an I-OPS press release, this not only improves efficiency in the operating room but in the clinic as a whole, as the staff is freed up to focus on tasks such as documentation; this helps increase patient throughput and improves the accuracy of clinic records.

The I-OPS is made for practices including ophthalmic, dermatology, oculoplastic or any other that performs frequent injections or uses small bottle solutions. OM