Original article
Implantable Telescope for End-Stage Age-related Macular Degeneration: Long-term Visual Acuity and Safety Outcomes

https://doi.org/10.1016/j.ajo.2008.07.003Get rights and content

Purpose

To evaluate long-term safety and best-corrected visual acuity (BCVA) results of a telescope prosthesis in patients with end-stage age-related macular degeneration (AMD).

Design

Prospective, open-label clinical trial with fellow-eye controls.

Methods

Patients with end-stage AMD (bilateral geographic atrophy or disciform scars; BCVA, 20/80 to 20/800) received the telescope prosthesis at 28 centers. Methods were similar to those described in the one-year results, with follow-up visits continuing at 18 and 24 months. Main outcome measures included BCVA change from baseline, endothelial cell density (ECD) and morphometry, and incidence of complications.

Results

At two years, data from 174 (92.6%) of 188 available patients were analyzed. Overall, 103 (59.5%) of 173 telescope-implanted eyes gained three lines or more (doubling of visual angle) of BCVA compared with 18 (10.3%) of 174 fellow control eyes (P < .0001). Mean BCVA improved 3.6 lines (standard deviation [SD], 1.9 lines) and 2.8 lines (SD, 2.3 lines) from baseline in eyes with the 3X and 2.2X device models, respectively. Mean ECD stabilized through two years, with 2.4% mean cell loss occurring from one to two years. There was no significant change in coefficient of variation or percentage of hexagonal endothelial cells from within six months to two years after surgery. The most common complication was inflammatory deposits.

Conclusions

Long-term results of this telescope prosthesis show the substantial BCVA improvement at one year is maintained at two years. Key indicators of corneal health demonstrate ECD change that reflects remodeling of the endothelium associated with the implantation procedure. ECD stabilizes over time, and there is no evidence of any ongoing endothelial trauma.

Section snippets

Methods

The study device, design, patient screening, surgical procedure, postoperative management, examination methods, and statistical methods have been described previously.12 The study device creates a new classification of ophthalmic surgical prosthetics—a telescope prosthesis. Fellow eyes served as a comparison because both eyes were required to have stable, untreatable AMD and central vision loss. Patients returned for examinations at 18 and 24 months after implantation to assess long-term visual

Demographics and Patient Retention

Baseline characteristics, demographic information, and operative results for this end-stage AMD study population (central scotomas resulting from bilateral geographic atrophy or disciform scars and bilateral BCVA from 20/80 to 20/800) have been described previously in detail.12 Overall, data from 174 (92.6%) of 188 available patients at two years were analyzed, or 84.5% of the original 206 implanted patients. Specifically, of the 206 patients implanted with the telescope prosthesis, 10 (4.9%)

Discussion

The current report on this prosthetic telescope procedure answers important questions regarding long-term safety and efficacy. Overall, similar to the one-year outcomes,12 the two-year results reflect the continued benefit of the device for this patient population with debilitating central vision loss resulting from bilateral geographic atrophy or disciform scars. Two-year endothelial cell counts and pachymetry further support the hypothesis that ECD is reduced during surgery, but then

Henry L. Hudson, MD, FACS, is in private practice in Tucson, Arizona. He completed his medical degree at USC, followed by post-graduate studies at UCLA, Doheny Eye Institute, USC and Retina Vitreous Associates in Los Angeles. Currently, Dr Hudson belongs to many ophthalmologic societies and has published several articles in peer-reviewed journals. He is also the lead Principal Investigator of numerous clinical research studies for the treatment of vitreo-retinal diseases and conditions.

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