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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Age Related Macular Degeneration

Intervention / Treatment
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* Device: Telescope prosthesis
* Device: WA-NG Telescope Prothesis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WA- NG Telescope Prothesis<br>Implantable Miniature Telescope for end stage AMD | Device: Telescope prosthesis<br>* Monocular implantation of the telescope prosthesis after cataract extraction<br>* Other names: IMT-NG;Device: WA-NG Telescope Prothesis<br>* The WA-NG telescope prosthesis (Figure 1) 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Positional stability assessed by slit lamp examination and anterior segment OCT | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | adverse events | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular Degeneration, Visual Impairment, Implantable Telescope