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

NCT ID: NCT04468373

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2020-07-31

Brief Summary

The purpose of this study is to evaluate the safety of the updated Model WA-NG telescope prosthesis (hereafter WA-NG telescope), an injectable telescope device, 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.

Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as specified in this protocol.

Conditions

Age Related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WA-NG (NG-IMT) Telescope Prothesis

Implantable Miniature Telescope for end stage AMD (Age-related Macular Degeneration)

Group Type: EXPERIMENTAL

WA-NG (NG-IMT) Telescope Prothesis

Intervention Type: DEVICE

The WA-NG telescope prosthesis 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.

Interventions

WA-NG (NG-IMT) Telescope Prothesis

The WA-NG telescope prosthesis 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.

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

• Patients with bilateral, stable, moderate to profound central vision impairment due to bilateral central scotoma associated with end-stage macular degeneration, defined as retinal findings of bilateral, geographic atrophy or disciform scar with foveal involvement.
• Patients must have distance BCVA between 20/80 and 20/800, and adequate peripheral vision in one eye (the non-implanted eye) to allow navigation
• Patients must achieve at least a five letter improvement on the ETDRS chart in the eye scheduled for surgery, with the external telescope simulator (ETS)
• Patients must be available for the study duration of 12 months
• Patients must be alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and be personally motivated to abide by the requirements and restrictions of the clinical trial.

• Evidence of active CNV on fluorescein angiography or treatment for CNV within the past six months.
• Patients who may require fellow eye cataract extraction and intraocular lens implantation during the 12 months following WA-NG telescope implantation. If fellow eye cataract extraction is anticipated, this procedure should be performed at least 30 days prior to enrollment in the clinical study.
• Patients who have had or are expected to have ophthalmic related surgery within the 30 days preceding implantation of the device.
• Patients who have undergone previous intraocular or corneal surgery of any kind in the operative eye(s), including any type of surgery for either refractive or therapeutic purposes.
• Patients participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VisionCare, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diane Gordon

Role: STUDY_DIRECTOR

VisionCare Ophthalmic Technologies

Locations

Mater Private Hospital

Dublin, , Ireland

VISSUM Ophthalmological Corporation

Alicante, , Spain

Countries

Ireland; Spain

Other Identifiers

WA-NG-001 EUROPE

Identifier Type: -

Identifier Source: org_study_id