Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration

VisionCare

Status and phase

Withdrawn

Early Phase 1

Conditions

Age Related Macular Degeneration

Treatments

Device: Telescope prosthesis

Device: WA-NG Telescope Prothesis

Study type

Interventional

Funder types

Industry

Identifiers

NCT01361256

WA-NG-001

Details and patient eligibility

About

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.

Full 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 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.

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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 involvement. Phakic in the operative eye. Must achieve a 5 letter improved with external telescope simulator. More medical

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 intraocular tumor or medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation.