Home Vision Monitoring Using the ForeseeHome Device Following Treatment of Neovascular Age Related Macular Degeneration

Study Overview
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Brief Summary
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ForeseeHome, an FDA-approved home device, was specifically designed for unsupervised Preferential-Hyperacuity-Perimeter (PHP) testing of Age Related Macular Degeneration (AMD) patients at home by characterizing central and paracentral metamorphopsia . The purpose of the current study is to evaluate if, in post-treatment patients, PHP parameters as measured with the ForeseeHome are in agreement with clinical decisions and retinal characteristics as measured with optical coherence tomography (OCT).

Official Title
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Home Vision Monitoring Using the ForeseeHome Device Following Treatment of Neovascular AMD

Conditions
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Age Related Macular Degeneration, Choroidal Neovascularization

Intervention / Treatment
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* Device: ForeseeHome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Received intravitreal antiangiogenic therapy for CNV in the study eye (SE), within 2-12 months prior to the study Last diagnosis was, and current diagnosis is, no CNV activity in SE eye Current plan in SE is clinical examination as standard care but at intervals of not more than 8 weeks. Visual acuity of 20/80 or better in SE Are capable and agree to sign a consent form and participate in the study Age > 55 year of age Are able to use a standard computer mouse correctly and without assistance Have a working telephone landline at the main residence (cellular communication maybe available for the study, and then eliminate this requirement) Clear view of the macular area on fundus photography Are willing to give their name and contact information to Notal Vision, supplier of the device, so that the company can provide direct services if needed (e.g., assist in using the home device, report the frequency of usage, coordinate replacement of devices in case of a technical problems, etc.) Agree to be examined by an ophthalmologist if SE shows symptoms of changes during the study Have a US address and do not plan on traveling abroad during the study period Fluent in English Perform a reliable ForeseeHome test during the enrollment visit Exclusion Criteria: Evidence of macular disease other than AMD or glaucoma in SE Presence of any significant media opacity that precludes a clear view of the macular area as identified in SE by biomicroscopy Any non-macular related ocular surgery performed within 3 months prior to study entry in SE Participant are not enrolled in another stuy that could affect the interval between clinical examinations, or the frequency of use of the ForeseeHome device

Ages Eligible for Study
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Minimum Age: 55 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1. Received therapy for CNV<br> | Device: ForeseeHome<br>* The ForeseeHomeTM device, was designed to identify central and paracentral irregularities (vision abnormalities) in the visual field, most commonly associated with exudative macular degeneration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the accuracy of the ForeseeHome to detect reactivation of CNV following successful treatment with Anti-VEGF |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the correlation between PHP measures and OCT measures |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CNV, AMD