June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
Long-Term (60-month) Results of the Implantable Miniature Telescope
Author Affiliations & Notes
  • Sumit Garg
    Gavin Herbert Eye Institute, University of California, Irvine, Irvine, CA
  • Footnotes
    Commercial Relationships Sumit Garg, VisionCare Ophthalmic Technologies (R)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 518. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract
 
Purpose
 

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.

 
Methods
 

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.

 
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), 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.

 
Conclusions
 

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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