Age Related Macular Degeneration Clinical Trial
Official title:
Pilot Study of WA-NG Telescope Prosthesis in Patients With Central Vision Impairment Associated 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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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