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Enrolling by invitation NCT01757132

Post-Approval Study of the Implantable Miniature Telescope

No phase Interventional AMD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implantable Miniature Telescope.
Who it may be relevant to
Registry conditions: AMD. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Post-approval Study of VisionCare's Implantable Miniature Telescope (by Dr. Isaac Lipshitz) in Patients With Bilateral Severe to Profound Central Vision Impairment Assoc. With End-stage Age-related Macular Degeneration

Overview

The objective of the PAS-01 study is to assess the safety of the intraocular as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity \>2 lines from pre-surgery baseline level). The study will test the null hypothesis that the percentage of patients who experience persistent vision-impairing corneal edema is \>17% against the alternative that the percentage is \<17%. The null hypothesis will be rejected if the upper bound of the two-sided 95% confidence integral for the observed percentage is \<17%.

Detailed description

ECD sub-study. At investigative sites participating in the ECD Sub-Group study, corneal endothelial cell density will be measured by non-contact specular microscopy in a subgroup of 150 patients enrolled in the IMT-PAS-01 in the eye schedule for and implanted with the intraocular telescope at study entry, 3 months, 12, months, 24 months, 36 months, 48 months and 60 months.

Interventions

  • Device Implantable Miniature Telescope
    Device - Implantable Miniature Telescope

Primary outcome measures

  • Long term safety study of implantable miniature telescope [Time frame: 5 years after implantation]

Eligibility criteria

Inclusion criteria

  • stable severe (BVDCA of 10/160 or poorer) to profound (BCDVA of 20/800 or better) vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration.
  • 65 years of age or older
  • retinal findings of geographic atrophy or disciform scar with foveal involvement
  • visually significant cataract
  • agree to undergo pre- and post-surgery training and assessment
  • achieve at least a 5-letter improvement with external telescope
  • have adequate peripheral vision in the eye not scheduled for surgery

Exclusion criteria

  • Stargardt's macular dystrophy
  • Anterior chamber depth < 3.0mm
  • Presence of corneal guttate
  • Do not meet minimum age and endothelial cell density requirements
  • evidence of CNV or treatment of CNV within the past 6 months
  • cognitive impairment that would interfere with ability to understand and complete Acceptance of Risk and Informed Decision Agreement or prevent proper training/rehabilitation
  • previous intraocular or cornea surgery of any kind in operative eye, including any type of surgery for either refractive or therapeutic purposes or who have prior or expected ophthalmic related surgery within 30 days preceding intraocular telescope surgery
  • history of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP >22 mm Hg while on maximum medication
  • known sensitivity to post-operative medications
  • history of eye rubbing or an ocular condition that predisposes eye rubbing
  • myopia >6.0 D
  • hyperopia >4.0D
  • axial length <21mm
  • narrow angle, i.e., <Schaffer grade 2
  • cornea stromal or endothelian dystrophies, including guttate
  • inflammatory ocular disease
  • zonular weakness/instability of crystalline lens, or pseudoexfoliation
  • diabetic retinopathy
  • untreated retinal tears
  • retinal vascular disease
  • optic nerve disease
  • history of retinal detachment
  • intraocular tumor
  • retinitis pigmentosa

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 16 centers
  • Arizona Eye Center — Chandler
  • Retinal Consultants of Arizona, LTD — Phoenix
  • Barnet, Dulaney, Perkins Eye — Phoenix
  • Retina-Vitreous Associates — Beverly Hills
  • Retina Consultants of Orange County — Fullerton
  • Loma Linda University Health Care — Loma Linda
  • University of California - Davis — Sacramento
  • Specialty Eye Care (Glaucoma Consultants of Colorado) — Parker
  • … and 8 more centers

Identifiers

NCT: NCT01757132 · PAS-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗