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M.B. Hamill, B.D. Kuppermann, I.H. Fine, S.S. Lane; The Implantable Miniature Telescope: 12-Month Results of the US IMT-001 Clinical Trial in Patients with Stable Age-Related Macular Degeneration . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4209.
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Background: The Implantable Miniature Telescope (IMT) is an investigational device that is implanted in the capsular bag, monocularly, in patients with bilateral, stable age-related macular degeneration (AMD). The implanted eye provides the patient magnified central vision, while the fellow eye provides peripheral vision for safe mobility and navigation. This intraocular low vision device utilizes natural eye movements and allows for a natural cosmetic appearance. Purpose: The purpose of this study is an initial US evaluation of the safety and efficacy of the IMT (VisionCare Ophthalmic Technologies, Saratoga, CA) in patients with significant bilateral central vision impairment due to disciform scar or atrophic AMD. Methods: A total of 14 patients (≥60 years of age) with stable, bilateral disciform scar or atrophic AMD, cataract, and visual acuity between 20/80 and 20/400 were implanted with the IMT in this prospective, multi-center trial. Distance and near best-corrected visual acuity (BCVA), endothelial cell density (ECD), and activities of daily living (ADL) were assessed at baseline, 3, 6, and 12 months. Results: The mean patient age was 80. All patients completed all follow-up visits except for one patient who died prior to the 12-month visit. At 6 months, 7 of 13 (54%) and 6 of 13 (46%) experienced a gain of 2 lines or more of distance or near BCVA, respectively. At 12 months, 10 of 13 (77%) patients experienced a gain of 2 lines or more in either distance or near BCVA and 8 of 13 (62%) gained 3 or more lines in either distance or near BCVA. Mean ECD decreased from baseline by 7% at 3 months, 13% at 6 months, with no further cell loss reported at 12 months. All adverse events resolved without sequelae, except for a single eye with persistent inflammation. ADL improved by 29% and 55% in those patients who experienced an improvement in either distance or near BCVA of 2 or more lines at 12 months. Conclusion: The majority of study patients experienced improvement in both visual acuity and activities of daily living. No serious adverse events were reported. These initial results support expansion of the clinical trial.
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