Vanessa Caceres, Jeffrey Whitman MD / Ophthalmology Times
The inlay, which is still an investigational device in the U.S., is inserted under a LASIK flap. It is a microscopic hydrogel inlay that creates a central steepening of the cornea to give a greater depth of focus, said Dr. Whitman, Key-Whitman Eye Center, Dallas.
“It’s an easy procedure for anyone who knows how to make a flap for LASIK surgery,” he said.
Dr. Whitman’s study included 81 patients and focused on quality of vision and patient satisfaction after a yearlong follow up. He collected visual acuity information at one week and other follow-ups at 1, 3, 6, 9, and 12 months.
Patients reported information on visual symptoms, visual task performance, and patient satisfaction with the use of National Eye Institute Refractive Error Quality of Life questionnaire.
At 1 year binocularly, 98% of patients had 20/20 or better uncorrected near visual acuity (UNVA), and 100% had 20/20 uncorrected distance visual acuity (UDVA). In the Raindrop Eye, 98% had 20/25 or better UNVA, and 96% had 20/32 or better UDVA.
Dr. Whitman found few moderate or worse visual symptoms after Raindrop Inlay implantation. There were no reports of glare, and only 2% of patients had halos at 1 year. There was no increased difficulty for driving at night. Six percent of patients reported dryness.
Looking at long reading—in other words, reading for more than 45 minutes, as someone might do with a book—the inlay made a difference in the percentage of patients who used glasses.
Ninety six percent used glasses all of the time preoperatively, compared with 62% who said they did not use glasses for long reading after Raindrop Inlay implantation. Nine percent of patients still used glasses all the time for long reading after inlay implantation, while some patients used glasses only occasionally.
The inlay also helped with the performance of work or hobbies at near. Ninety one percent said they had little or no difficulty with these tasks 1 year after inlay implantation, compared with 29% preoperatively.
“Whether it be coin collecting or computer work or reading, the majority did well,” Dr. Whitman said.
Previous trials have found a one-line decrease in uncorrected distance visual acuity with the Raindrop, Dr. Whitman said. However, when asked about playing active sports—which tend to be more distance predominant—14% had less difficulty after inlay insertion.
“It’s probably from a wider range of vision,” Dr. Whitman said. Although patients may experience a slight decrease in distance vision, it appears to be minimal enough to not affect visual quality or satisfaction, he explained.
Ninety six percent of patients were satisfied or very satisfied with their visual results.
Dr. Whitman concluded by noting that the inlay could be an option for presbyopic patients with an active lifestyle. A number of patients in the study said they felt better about themselves with the inlay as they didn’t feel they had the stigma of taking glasses on and off in a group of mixed-age coworkers, or it made them feel younger.
The company that makes the inlay continues to study the device and are working toward eventual U.S. FDA approval. The inlay may help both patients with good distance vision who have lost their near vision and possibly patients with previous cataract surgery who still have to use glasses, Dr. Whitman said.
A second study is under way with pseudophakes.
Recently, the KAMRA cornea inlay (AcuFocus) for presbyopia was approved by the FDA in the United States.
Jeffrey Whitman, MD
This article was adapted from Dr. Whitman’s presentation at the 2015 meeting of the American Society of Cataract and Refractive Surgery. He did not indicate any financial interest in the subject matter.
Russian pharmaceutical company NovaMedica, a portfolio company of RUSNANO, announces the start of construction of a plant for the production of sterile injectable drugs as part of its long-term strategy to localize innovative medicines and technologies of their development and production in Russia. The plant will be built in the industrial park “Vorsino” in the Kaluga region.
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