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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01361256
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : May 26, 2011
Last Update Posted : October 31, 2016
Information provided by (Responsible Party):
VisionCare, Inc.

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.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Device: Telescope prosthesis Device: WA-NG Telescope Prothesis Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of WA-NG Telescope Prosthesis in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration
Study Start Date : May 2011
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: WA- NG Telescope Prothesis
Implantable Miniature Telescope for end stage AMD (Age-related Macular Degeneration)
Device: Telescope prosthesis
Monocular implantation of the telescope prosthesis after cataract extraction
Other Name: IMT-NG
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.

Primary Outcome Measures :
  1. Positional Stability [ Time Frame: 12 months ]
    Positional stability assessed by slit lamp examination and anterior segment OCT

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 12 months ]
    adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01361256

Sheba Medical Center
Tel Hasomer, Israel, 52621
Sponsors and Collaborators
VisionCare, Inc.
Principal Investigator: Mordecai Rosner, MD Sheba Medical Center

Responsible Party: VisionCare, Inc. Identifier: NCT01361256     History of Changes
Other Study ID Numbers: WA-NG-001
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016

Keywords provided by VisionCare, Inc.:
Macular Degeneration
Visual Impairment
Implantable Telescope

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases