Status:
TERMINATED
Study of WA-NG (NG-IMT) Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
Lead Sponsor:
VisionCare, Inc.
Conditions:
Age Related Macular Degeneration
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety of the updated Model WA-NG telescope prosthesis (hereafter WA-NG telescope), an injectable telescope device, in patients with bilateral moderate to ...
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 exami...
Eligibility Criteria
Inclusion
- \*\*The following Inc. \& Exc. are sample and not completed list \*\*
- Main Exclusion Criteria:
- Patients with bilateral, stable, moderate to profound central vision impairment due to bilateral central scotoma associated with end-stage macular degeneration, defined as retinal findings of bilateral, geographic atrophy or disciform scar with foveal involvement.
- Patients must have distance BCVA between 20/80 and 20/800, and adequate peripheral vision in one eye (the non-implanted eye) to allow navigation
- Patients must achieve at least a five letter improvement on the ETDRS chart in the eye scheduled for surgery, with the external telescope simulator (ETS)
- Patients must be available for the study duration of 12 months
- Patients must be alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and be personally motivated to abide by the requirements and restrictions of the clinical trial.
- Main Exclusion Criteria:
- Evidence of active CNV on fluorescein angiography or treatment for CNV within the past six months.
- Patients who may require fellow eye cataract extraction and intraocular lens implantation during the 12 months following WA-NG telescope implantation. If fellow eye cataract extraction is anticipated, this procedure should be performed at least 30 days prior to enrollment in the clinical study.
- Patients who have had or are expected to have ophthalmic related surgery within the 30 days preceding implantation of the device.
- Patients who have undergone previous intraocular or corneal surgery of any kind in the operative eye(s), including any type of surgery for either refractive or therapeutic purposes.
- Patients participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation
Exclusion
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04468373
Start Date
May 1 2015
End Date
July 1 2020
Last Update
July 13 2020
Active Locations (2)
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1
Mater Private Hospital
Dublin, Ireland
2
VISSUM Ophthalmological Corporation
Alicante, Spain