CNV: Home Vision Monitoring Using the ForeseeHome Device Following Treatment of Neovascular Age Related Macular Degeneration
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1. Received therapy for CNV
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Device: ForeseeHome
The ForeseeHomeTM device, was designed to identify central and paracentral irregularities (vision abnormalities) in the visual field, most commonly associated with exudative macular degeneration.
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Outcome Measures
Primary Outcome Measures
- Assess the accuracy of the ForeseeHome to detect reactivation of CNV following successful treatment with Anti-VEGF [1 year]
Secondary Outcome Measures
- Evaluate the correlation between PHP measures and OCT measures [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Received intravitreal antiangiogenic therapy for CNV in the study eye (SE), within 2-12 months prior to the study
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Last diagnosis was, and current diagnosis is, no CNV activity in SE eye
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Current plan in SE is clinical examination as standard care but at intervals of not more than 8 weeks.
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Visual acuity of 20/80 or better in SE
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Are capable and agree to sign a consent form and participate in the study
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Age > 55 year of age
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Are able to use a standard computer mouse correctly and without assistance
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Have a working telephone landline at the main residence (cellular communication maybe available for the study, and then eliminate this requirement)
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Clear view of the macular area on fundus photography
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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.)
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Agree to be examined by an ophthalmologist if SE shows symptoms of changes during the study
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Have a US address and do not plan on traveling abroad during the study period
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Fluent in English
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Perform a reliable ForeseeHome test during the enrollment visit
Exclusion Criteria:
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Evidence of macular disease other than AMD or glaucoma in SE
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Presence of any significant media opacity that precludes a clear view of the macular area as identified in SE by biomicroscopy
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Any non-macular related ocular surgery performed within 3 months prior to study entry in SE
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Participant are not enrolled in another stuy that could affect the interval between clinical examinations, or the frequency of use of the ForeseeHome device
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Retina Care specisalists | Palm Beach Gardens | Florida | United States | |
| 2 | Elman retina group | Baltimore | Maryland | United States | |
| 3 | Pepose Vision Institute | St. Louis | Missouri | United States |
Sponsors and Collaborators
- Notal Vision Ltd.
Investigators
- Principal Investigator: Mark Michels, MD, Retina care specialists
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PT US 001.2