VIENNA — For patients with bilateral late-stage age-related macular degeneration (AMD), an implantable miniature telescope is effective in patients younger than 75 years, according to results of a 5-year study.
"Younger patients probably have a greater ability to adapt," David Boyer, MD, from the University of Southern California in Los Angeles, told Medscape Medical News.
The miniature telescope, developed by VisionCare Ophthalmic Technologies, was approved by the US Food and Drug Administration (FDA) in 2010 for use in patients aged 75 years and older with moderate to severe central visual impairment from end-stage macular degeneration. Earlier results from this study supported the approval.
At the request of the FDA, Dr Boyer and colleagues extended the study to look at long-term results. They also conducted a subgroup analysis for patients according to age.
On the basis of their findings, the indication for the telescope was expanded by the FDA to include patients aged 65 to 75 years in October 2014.
The data were published online June 17 in the Journal of Clinical Ophthalmology and presented here at the American Society of Retina Specialists (ASRS) 2015 Annual Meeting.
The miniature telescope can help patients whose AMD makes the typical lens replacement for cataract treatment less effective. In such patients, "if you put a regular lens in, it focuses the light to the area of the retina that is damaged," Dr Boyer explained.
Instead, the miniature telescope focuses on an undamaged part of the retina. "It allows them to see their grandchildren," he said.
After removing the eye's lens, surgeons place the implant in the capsular bag. It uses natural eye movements to provide 2.7 times magnification.
Study Details
The researchers followed 217 patients who underwent implantation in one eye; the fellow eye served as the control group.
The mean age of the patients was 76 years. All had AMD and moderate to profound bilateral central visual acuity loss (20/80 to 20/800) from untreatable geographic atrophy, disciform scars, or both.
For the analysis, the patients were stratified by age at study enrollment: 75 years and older, 65 to 75 years, and younger than 65 years.
At 5 years, best corrected distance visual acuity improved in all age groups, with an overall mean improvement of 2.41 lines. However, the improvement in acuity was better in patients younger than 75 years than in those older than 75 years.
The younger patients also reported greater improvement in quality of life, measured on the Vision Function Quality Questionnaire.
The device was removed in eight patients because they were dissatisfied and in four patients because of complications.
Iritis that developed more than 30 days after surgery was significantly more common in patients aged 65 to 75 years than in those aged 75 years and older (10.0% vs 3.9%).
A decrease in best corrected distance visual acuity of 2 lines or more 30 days after implantation was less common in patients aged 65 to 75 years than in those aged 75 years and older (5.7% vs 7.9%).
For all patients older than 65 years, there was a mean endothelial cell density loss of 20% at 3 months; chronic loss was 3% per year.
Of the 20 patients who were younger than 65 years at study enrollment, five experienced adverse events, three of which were posterior capsule rupture.
Table. Five-Year Results
| Age | |||
| Outcome | <65 Years | 65 to 75 Years | >75 Years |
| Mean corrected distance improvement, lines | 2.58 | 2.64 | 2.09 |
| Gain of ≥3 lines, % | 46.2 | 58.1 | 37.5 |
| Chronic endothelial cell density loss, % | 31 | 35 | 40 |
| Cornea transplantation, n | 0 | 2 | 2 |
| Device removal, n | 1 | 1 | 10 |
The researchers conclude that the telescope implantation is viable in patients in all three age groups.
However, patient selection poses a significant challenge, according to session moderator David Brown, MD, from the Baylor College of Medicine in Houston, Texas.
"We've had some patients who just loved it, and some who have had to have it explanted," he told Medscape Medical News.
The device restricts peripheral vision in the implanted eye. Although the other eye can compensate, implanted patients cannot drive, and even some of those who have already given up driving find the change hard to accept, Dr Brown reported.
The study was funded by VisionCare Ophthalmic Technologies. Dr Boyer reports financial relationships with VisionCare, Alcon, Allergan, Aerpio Therapeutics, Allegro Ophthalmics, Santen Pharmaceutical, Genentech, Bayer, Novartis, Regenron Pharmaceuticals, ThromboGenics, and Ohr Pharmaceutical. Dr Brown has disclosed no relevant financial relationships.
American Society of Retina Specialists (ASRS) 2015 Annual Meeting. Presented July 11, 2015.
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Cite this: Implantable Telescope Effective in AMD Patients Younger Than 75 - Medscape - Jul 13, 2015.
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