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

NCT01731964 | Withdrawn

• 1 other identifier: WA-NG-001 ASSAF HAROFEH
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age Related Macular Degeneration

Keywords

Macular Degeneration; Visual Impairment; Implantable Telescope

Outcome Measures

Primary Outcomes (1)

• Safety

  Positional stability assessed by slit lamp examination and anterior segment OCT

  12 months

Secondary Outcomes (1)

• Safety

  12 months

Study Arms (1)

WA- NG Telescope Prothesis

EXPERIMENTAL

Implantable Miniature Telescope for end stage AMD

Device: Telescope prosthesis; Device: WA-NG Telescope Prothesis

Interventions

Telescope prosthesis DEVICE

Monocular implantation of the telescope prosthesis after cataract extraction

Also known as: IMT-NG

WA- NG Telescope Prothesis

WA-NG Telescope Prothesis DEVICE

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.

WA- NG Telescope Prothesis

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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 involvment. Phakic in the operative eye. Must achieve a 5 letter improved with external telescope simulator.

You may not qualify if:

• 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 introcular tumor or medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation.

Sponsors & Collaborators

• VisionCare, Inc.: lead

Study Sites (1)

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Macular Degeneration; Vision Disorders

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Isaac Avni, MD

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 22, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: December 11, 2014

Record last verified: 2014-04

Locations

IL (1)