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Sumit Garg, ; Long-Term (60-month) Results of the Implantable Miniature Telescope. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):518.
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As a result of the profound visual impairment associated with end-stage age-related macular degeneration (AMD), patients experience a substantial reduction in quality of life (QoL), increased dependency on caregivers, and depression. We hypothesized an implantable miniature telescope (IMT; VisionCare Ophthalmic Technologies, Saratoga, CA) would prove both efficacious and safe over the long term (60 months), and that younger patients would fare at least as well as older patients.
A prospective, open-label, multicenter clinical trial enrolled 217 patients (mean age, 76 years) with AMD and moderate-to-profound bilateral central visual acuity loss (20/80-20/800) resulting from untreatable geographic atrophy, disciform scars, or both, who underwent unilateral IMT implantation. A subgroup analysis was stratified by age (patients age 65 to <75 years [Group 1] and those age ≥75 years [Group 2]) and comparatively evaluated best-corrected distance visual acuity (BCDVA), quality of life (QoL), surgical complications, adverse events, and endothelial cell density change (ECD). Follow-up in an extension study was 60 months.
Data were available for 22, 38, and 31 patients in Group 1 and 42, 46, and 32 patients in Group 2 at 36, 48, and 60 months, respectively. Mean BCDVA improvement from baseline to 60 months was 2.41(± 2.69) lines in all patients (n=76), 2.64(± 2.55) lines in Group 1 and 2.09(± 2.88) lines in Group 2. QoL scores were significantly higher in Group 1. The most common significant surgical complications in Group 1 were iritis > 30 days after surgery (7/70, 10%) and persistent corneal edema (3/70; 4.3%); in Group 2, decrease in BCDVA in the implanted eye or IMT removal (10/127 each; 7.9%) and corneal edema > 30 days after surgery (9/127; 7.1%). Significant adverse events included 4 cornea transplants, 2 (2.9%) in Group 1 and 2 (1.6%) in Group 2. The IMT was removed in 1 (1.4%) and 10 (7.9%) patients in Group 1 and Group 2, respectively. Mean ECD loss was 20% at 3 months. Chronic loss was 3.0% per year, and was less in Group 1 than Group 2 (35% vs.40%, respectively) at 60 months.
Long-term results show substantial BDCVA improvement retention. The IMT performed as well in Group 1 as it did in Group 2 through month 60. Younger patients retained more vision than their older counterparts and had fewer adverse events.
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