Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
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|ClinicalTrials.gov Identifier: NCT01731964|
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : November 22, 2012
Last Update Posted : December 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Age Related Macular Degeneration||Device: Telescope prosthesis Device: WA-NG Telescope Prothesis||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of WA-NG Telescope Prosthesis in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2015|
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.
- Safety [ Time Frame: 12 months ]Positional stability assessed by slit lamp examination and anterior segment OCT
- Safety [ Time Frame: 12 months ]adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731964
|Assaf Harofeh Medical Center|
|Zerifin, Israel, 70300|
|Principal Investigator:||Isaac Avni, MD||Assaf-Harofeh Medical Center|