Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
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.
Age Related Macular Degeneration
Device: Telescope prosthesis
Device: WA-NG Telescope Prothesis
|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|
- Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Positional stability assessed by slit lamp examination and anterior segment OCT
- Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]adverse events
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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-NGDevice: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731964
|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 email@example.com|
|Principal Investigator: Isaac Avni, MD|
|Principal Investigator:||Isaac Avni, MD||Assaf-Harofeh Medical Center|