Implantable Telescope for End-Stage Age-related Macular Degeneration: Long-term Visual Acuity and Safety Outcomes HENRY L. HUDSON, R. DOYLE STULTING, JEFFREY S. HEIER, STEPHEN S. LANE, DAVID F. CHANG, LAWRENCE J. SINGERMAN, CYNTHIA A. BRADFORD, AND ROBERT E. LEONARD, ON BEHALF OF THE IMT002 STUDY GROUP ● PURPOSE: To evaluate long-term safety and best-cor- rected 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 fel- low-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 mor- phometry, 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 im- plantation procedure. ECD stabilizes over time, and there is no evidence of any ongoing endothelial trauma. (Am J Ophthalmol 2008;146:664 – 673. © 2008 by Elsevier Inc. All rights reserved.) U NTREATABLE END-STAGE AGE-RELATED MACULAR degeneration (AMD) is a growing public health problem in developed countries. 1– 4 It remains largely unresolved because currently available treatments for exudative AMD are not consistently effective, 5 and there are as yet no pharmacotherapeutic interventions available for atrophic disease. Therefore, the number of individuals af- fected by end-stage AMD (bilateral scotomas resulting from nonfoveal sparing disciform or atrophic AMD) continues to rise. This most advanced stage of AMD deprives approxi- mately 60,000 to 80,000 people of their central vision in the United States each year, the vast majority being severely visually impaired elderly individuals. 1,6,7 The need for new treatment approaches for end-stage forms of AMD clearly is evident when we consider the debilitating influence of AMD on a patient’s life. Utility values show moderate AMD produces a 40% decrease in quality of life, 8 similar to the reduction associated with severe angina or permanent renal dialysis, and very severe AMD causes a 63% reduction, a diminution “similar to that en- countered with advanced prostatic cancer with uncontrolla- ble pain or a severe stroke that leaves a person bedridden, incontinent and requiring constant nursing care.” 8 The in- herent value of central vision to this population is emphasized by the fact that individuals with severe macular degeneration would give half of their remaining years of life to have normal vision. 9 The economic impact associated with severe visual impairment because of AMD, quantified by total direct and caregiver costs, is estimated to be $50,000 per year. 10 Patients with bilateral advanced or end-stage AMD also demonstrate significantly lower National Eye Institute Visual Function Questionnaire (NEI VFQ) quality of life scores than individuals with milder forms of AMD. 11–13 Improving out- comes in end-stage visually impaired patients is difficult. A recent systematic review of 72 studies of AMD and low-vision rehabilitation did not show any evidence of improved quality of life in patient populations with end-stage AMD. 14 The authors identified both variability in study methodology and varying levels of visual impairment as challenging factors to analyze or predict effective strategies. Accepted for publication Jul 1, 2008. From Retina Centers, P.C., Tucson, Arizona (H.L.H.); the Emory University Eye Center, Atlanta, Georgia (R.D.S.); Ophthalmic Consult- ants of Boston, Boston, Massachusetts (J.S.H.); Associated Eye Care, Stillwater, Minnesota (S.S.L.); Altos Eye Physicians, Los Altos, Califor- nia (D.F.C.); Retina Associates of Cleveland, Cleveland, Ohio (L.J.S.); and the Dean A. McGee Eye Institute, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma (C.A.B., R.E.L.). Inquiries to Henry L. Hudson, 6585 North Oracle Road, Suite A, Tucson, AZ 85704; e-mail: henhud@msn.com © 2008 BY ELSEVIER INC.ALL RIGHTS RESERVED. 664 0002-9394/08/$34.00 doi:10.1016/j.ajo.2008.07.003