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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by VisionCare Ophthalmic Technologies, Inc.
Sponsor:
Information provided by (Responsible Party):
VisionCare Ophthalmic Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01361256
First received: May 24, 2011
Last updated: April 30, 2014
Last verified: April 2014
  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 Phase
Age Related Macular Degeneration
Device: Telescope prosthesis
Device: WA-NG Telescope Prothesis
Phase 0

Study Type: Interventional
Study Design: 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:


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: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361256

Locations
Israel
Sheba Medical Center Recruiting
Tel Hasomer, Israel, 52621
Contact: Mordecai Rosner, MD    +972-3-5302957    mrosner@post.tau.ac.il   
Contact: Rinat Cohen, B.A    972-3-5302877    rinat.rashty@sheba.health.gov.il   
Principal Investigator: Mordecai Rosner, MD         
Sponsors and Collaborators
VisionCare Ophthalmic Technologies, Inc.
Investigators
Principal Investigator: Mordecai Rosner, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: VisionCare Ophthalmic Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01361256     History of Changes
Other Study ID Numbers: WA-NG-001
Study First Received: May 24, 2011
Last Updated: April 30, 2014
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 September 16, 2014