Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration

Overview

This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.

Full Title of Study: “Pilot Study of WA-NG Telescope Prosthesis in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2015

Detailed Description

Patients will be screened for eligibility and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible patients will be examined preoperatively to obtain a medical history and to establish a baseline for ocular condition. Baseline measurements will include successful use of an external telescope.

Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as specified in this protocol and will be required to return for 6 to 10 additional visits for vision training with a low vision specialist.

Interventions

  • Device: Telescope prosthesis
    • Monocular implantation of the telescope prosthesis after cataract extraction
  • Device: WA-NG Telescope Prothesis
    • The WA-NG telescope prosthesis (Figure 1) is the next generation telescopic implantable device which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with severe to profound vision impairment due to bilateral, end-stage age-related macular degeneration. The device is implanted in one of the patient’s eyes. In this way, the implanted eye provides central vision and the non-implanted eye can continue to provide peripheral vision.

Arms, Groups and Cohorts

  • Experimental: WA- NG Telescope Prothesis
    • Implantable Miniature Telescope for end stage AMD (Age-related Macular Degeneration)

Clinical Trial Outcome Measures

Primary Measures

  • Positional Stability
    • Time Frame: 12 months
    • Positional stability assessed by slit lamp examination and anterior segment OCT

Secondary Measures

  • Adverse events
    • Time Frame: 12 months
    • adverse events

Participating in This Clinical Trial

Inclusion Criteria

  • Bi-lateral, stable, moderate to profound (20/80 to 20/800) central vision impairment due to bilateral scotoma associated with end-stage macular degeneration, defined as retinal finds of bilateral, geographic atrophy or disciform scar with foveal involvement. Phakic in the operative eye. Must achieve a 5 letter improved with external telescope simulator. More medical

Exclusion Criteria

  • Evidence of active CNV or any ophthalmic pathology that compromises peripheral vision of fellow eye or predisposes eye rubbing. Previous intraocular of corneal surgery of any kind in operative eye. Retinal disease, optic nerve disease, diabetic retinopathy, retinal tears, or any intraocular tumor or medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation.

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VisionCare, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mordecai Rosner, MD, Principal Investigator, Sheba Medical Center

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