Pilot Study of WA-NG Telescope Prosthesis in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration
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.
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.