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OpenTrials
Completed

NCT Number: NCT01334294

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

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).

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Key information

Conditions

Age Related Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Retina Care specisalists, Palm Beach Gardens, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ForeseeHome

Device

The ForeseeHomeTM device, was designed to identify central and paracentral irregularities (vision abnormalities) in the visual field, most commonly associated with exudative macular degeneration.

Primary outcomes

  1. Assess the accuracy of the ForeseeHome to detect reactivation of CNV following successful treatment with Anti-VEGF

    Time frame: 1 year

Secondary outcomes

  1. Evaluate the correlation between PHP measures and OCT measures

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Notal Vision Ltd.

Industry

Registry information

Official study title

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

Acronym: CNV

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Apr 13, 2011
Registry last updated
Oct 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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