Back to resultsStudy of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
Primary Purpose
Age Related Macular Degeneration
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Telescope prosthesis
WA-NG Telescope Prothesis
Sponsored by
About this trial
This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring Macular Degeneration, Visual Impairment, Implantable Telescope
Eligibility 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.
Sites / Locations
- Assaf Harofeh Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WA- NG Telescope Prothesis
Arm Description
Implantable Miniature Telescope for end stage AMD
Outcomes
Primary Outcome Measures
Safety
Positional stability assessed by slit lamp examination and anterior segment OCT
Secondary Outcome Measures
Safety
adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01731964
Brief Title
Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
Official Title
Pilot Study of WA-NG Telescope Prosthesis in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VisionCare, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
Macular Degeneration, Visual Impairment, Implantable Telescope
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WA- NG Telescope Prothesis
Arm Type
Experimental
Arm Description
Implantable Miniature Telescope for end stage AMD
Intervention Type
Device
Intervention Name(s)
Telescope prosthesis
Other Intervention Name(s)
IMT-NG
Intervention Description
Monocular implantation of the telescope prosthesis after cataract extraction
Intervention Type
Device
Intervention Name(s)
WA-NG Telescope Prothesis
Intervention Description
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 Measure Information:
Title
Safety
Description
Positional stability assessed by slit lamp examination and anterior segment OCT
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Safety
Description
adverse events
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isaac Avni, MD
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
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