Purchase this article with an account.
H.L. Hudson, IMT002 Study Group; Results of a Visual Prosthetic Device for the Treatment of Central Vision Loss Due to Age–Related Macular Degeneration (IMT002 Trial) . Invest. Ophthalmol. Vis. Sci. 2006;47(13):3211.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
Despite recent advances in the treatment of choroidal neovascularization (CNV), many patients progress to moderate, severe, or profound visual impairment caused by central scotomata that affect distance and near vision. Likewise, no treatments are available for geographic atrophy. This trial evaluated the safety and efficacy of the Implantable Miniature Telescope,* a micro–optical visual prosthetic device, for the treatment of vision loss due to bilateral untreatable, end–stage AMD. The device is designed to reduce the relative size of the scotoma caused by the macular lesion.
217 patients age 55 and older with bilateral cicatricial or atrophic AMD and best–corrected visual acuity (BCVA) 20/80 to 20/800 were enrolled in this prospective, multicenter trial. Exclusion criteria included evidence or treatment of CNV in the preceding 6 months. 206 patients were successfully implanted monoculary with the visual prosthesis. Patients were treated and managed by a multi–specialty team, which included postoperative visual rehabilitation (6 sessions). Outcome measures were change in BCVA and quality of life (NEI VFQ–25 and Activities of Daily Life (ADL) scales). Fellow eyes served as a control.
Mean age was 76 years and baseline BCVA was 20/316 at distance and 20/250 at near. At one year, distance and near BCVA improved 3.5 and 3.2 lines from baseline in implanted eyes compared to 0.8 and 1.8 lines, respectively, in fellow eye controls (p<.0001). 96.3% (185/192) of patients had stable or improved distance BCVA. A gain of 3 or more lines of both distance and near BCVA was achieved in 53% of implanted eyes compared to 10% of fellow eye controls (p<.0001). NEI VFQ–25 scores improved significantly from baseline (p<.01) on 7 of 8 relevant subscales. ADL scores showed statistically significant improvement in all subscales of activities of daily life (distance, intermediate, and near vision in static or dynamic tasks). ECD loss at one–year was 25.3%. During the implantation procedure, there were 2 choroidal hemorrhages and 1 device dropped into the vitreous. Postoperatively, one wet membrane developed at 6 months and was successfully treated by laser photocoagulation. Explants were required in 3 eyes (1.5%) due to device failure (2 eyes) and patient dissatisfaction (1 eye).
One–year results show this AMD visual prosthesis is effective in improving both visual acuity and quality of life in patients with untreatable, end–stage AMD. Longer–term results and the multi–specialty patient management paradigm will also be presented. *IMT by Dr. Isaac Lipshitz; VisionCare Ophthalmic Technologies, Saratoga, CA.
This PDF is available to Subscribers Only