Clinical trial NCT01334294: Home Vision Monitoring Using the ForeseeHome Device Following Treatment of Neovascular Age Related Macular Degeneration
Official title: Home Vision Monitoring Using the ForeseeHome Device Following Treatment of Neovascular AMD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Choroidal Neovascularization
Keywords: CNV
AMD
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2011-04-13
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Wet AMD

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).


Eligibility criteria: Inclusion Criteria:

1. Received intravitreal antiangiogenic therapy for CNV in the study eye (SE), within 2-12 months prior to the study
2. Last diagnosis was, and current diagnosis is, no CNV activity in SE eye
3. Current plan in SE is clinical examination as standard care but at intervals of not more than 8 weeks.
4. Visual acuity of 20/80 or better in SE
5. Are capable and agree to sign a consent form and participate in the study
6. Age \> 55 year of age
7. Are able to use a standard computer mouse correctly and without assistance
8. Have a working telephone landline at the main residence (cellular communication maybe available for the study, and then eliminate this requirement)
9. Clear view of the macular area on fundus photography
10. 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.)
11. Agree to be examined by an ophthalmologist if SE shows symptoms of changes during the study
12. Have a US address and do not plan on traveling abroad during the study period
13. Fluent in English
14. Perform a reliable ForeseeHome test during the enrollment visit

Exclusion Criteria:

1. Evidence of macular disease other than AMD or glaucoma in SE
2. Presence of any significant media opacity that precludes a clear view of the macular area as identified in SE by biomicroscopy
3. Any non-macular related ocular surgery performed within 3 months prior to study entry in SE
4. Participant are not enrolled in another stuy that could affect the interval between clinical examinations, or the frequency of use of the ForeseeHome device

Primary outcomes:
measure: Assess the accuracy of the ForeseeHome to detect reactivation of CNV following successful treatment with Anti-VEGF
timeFrame: 1 year
Secondary outcomes:
measure: Evaluate the correlation between PHP measures and OCT measures
timeFrame: 1 year
Other outcomes:
Locations:
city: Palm Beach Gardens
country: United States
facility: Retina Care specisalists
state: Florida
city: Baltimore
country: United States
facility: Elman retina group
state: Maryland
city: St. Louis
country: United States
facility: Pepose Vision Institute
state: Missouri
Study officials:
affiliation: Retina care specialists
name: Mark Michels, MD
role: PRINCIPAL_INVESTIGATOR
References: