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

This study is currently recruiting participants.
Verified November 2012 by VisionCare Ophthalmic Technologies, Inc.
Sponsor:
Information provided by (Responsible Party):
VisionCare Ophthalmic Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01731964
First received: November 14, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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 Intervention
Age Related Macular Degeneration
 Device: Telescope prosthesis
Device: WA-NG Telescope Prothesis

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VisionCare Ophthalmic Technologies, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Positional stability assessed by slit lamp examination and anterior segment OCT


Secondary Outcome Measures:
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    adverse events


Estimated Enrollment: 10
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WA- NG Telescope Prothesis
Implantable Miniature Telescope for end stage AMD
 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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731964

Locations
Israel
Assaf Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Isaac Avni, MD     +972-8-9779358     IzakA@asaf.health.gov.il    
Contact: Ella Shvalov     972-8-9204240     assaf.research@gmail.com    
Principal Investigator: Isaac Avni, MD            
Sponsors and Collaborators
VisionCare Ophthalmic Technologies, Inc.
Investigators
Principal Investigator: Isaac Avni, MD Assaf-Harofeh Medical Center
  More Information

No publications provided

Responsible Party: VisionCare Ophthalmic Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01731964     History of Changes
Other Study ID Numbers: WA-NG-001 ASSAF HAROFEH
Study First Received: November 14, 2012
Last Updated: November 14, 2012
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 23, 2013