Long-term (60-month) results for the implantable miniature telescope: efficacy and safety outcomes stratified by age in patients with end-stage age-related macular degeneration

Long-term (60-month) results for the implantable miniature telescope: efficacy and safety outcomes stratified by age in patients with end-stage age-related macular degeneration

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David Boyer,1 K Bailey Freund,2 Carl Regillo,3 Marc H Levy,4 Sumit Garg5 1Retina-Vitreous Associates Medical Group, Beverly Hills, CA, 2Vitreous-Retina-Macula Consultants of New York, New York, NY; 3Wills Eye Institute, Philadelphia, PA, 4Sarasota Retina Institute, Sarasota, FL, 5The Gavin Herbert Eye Institute (University of California, Irvine) Irvine, CA, USA Background: The purpose of this study kt196 torque converter was to evaluate the long-term results of an implantable miniature telescope (IMT) in patients with bilateral, end-stage, age-related macular degeneration (AMD).Methods: A prospective, open-label, multicenter clinical trial with fellow eye controls 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.A subgroup analysis was performed with stratification for age (patient age 65 to <75 years [group 1; n=70] and patient age ≥75 years [group 2; n=127]), with a comparative evaluation of change in best-corrected distance visual acuity (BCDVA), quality of life, ocular complications from surgery, adverse events, and endothelial cell density (ECD).

Follow-up in an extension study was 60 months.Results: 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), with 2.64±2.

55 lines in group 1 and 2.09±2.88 lines in group 2.

Quality of life scores were significantly higher in group 1.The most common significant surgery-related ocular complications in group 1 were iritis >30 days after surgery (7/70; 10%) and persistent corneal edema (3/70; 4.3%); and in group 2 were a decrease in BCDVA in the implanted eye or IMT removal (10/127 each; 7.

9%), corneal edema >30 days after surgery (9/127; 7.1%), and persistent corneal edema (6/127; 4.7%).

Significant adverse events included four corneal transplants, comprising two (2.9%) in group 1 and two (1.6%) in group 2.

At 60 months, one patient in group 1 (3.2%) and three patients in group 2 (9.4%) had lost ≥2 lines of vision.

The IMT was removed in one (1.4%) and ten (7.9%) patients in lochby venture pouch group 1 and group 2, respectively.

Mean ECD loss was 20% at 3 months.Chronic loss was 3% per year.ECD loss was less in group 1 than in group 2 (35% versus 40%, respectively) at 60 months.

Conclusion: Long-term results show substantial retention of improvement in BDCVA.Chronic ECD loss was consistent with that reported for conventional intraocular lenses.The IMT performed as well in group 1 (the younger group) as it did in group 2 through month 60.

Younger patients retained more vision than their older counterparts and had fewer adverse events.Although not a specified outcome for this study, patients younger than 65 years also fared better than those in group 2 and retained more vision with fewer adverse events through month 60.Keywords: end-stage age-related macular degeneration, implantable miniature telescope, low vision.