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

Not Applicable

Withdrawn

• Conditions: Age Related Macular Degeneration
• Interventions: Device: Telescope prosthesis; Device: WA-NG Telescope Prothesis

• Registration Number: NCT01731964
• Lead Sponsor: VisionCare, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-22
• Status Verified: 2014-04
• Primary Completion: 2014-12
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-11
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WA- NG Telescope Prothesis	Telescope prosthesis	Implantable Miniature Telescope for end stage AMD
WA- NG Telescope Prothesis	WA-NG Telescope Prothesis	Implantable Miniature Telescope for end stage AMD

Primary Outcome Measures

Name	Time	Method
Safety	12 months	Positional stability assessed by slit lamp examination and anterior segment OCT

Secondary Outcome Measures

Name	Time	Method
Safety	12 months	adverse events

Trial Locations

Locations (1)

Assaf Harofeh Medical Center; 🇮🇱 Zerifin, Israel