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

NCT01334294 | Completed

• 1 other identifier: PT US 001.2
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 3

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).

Conditions

Age Related Macular Degeneration; Choroidal Neovascularization

Keywords

CNV; AMD

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (1)

• Evaluate the correlation between PHP measures and OCT measures

  1 year

Study Arms (1)

1. Received therapy for CNV

Device: ForeseeHome

Interventions

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.

1. Received therapy for CNV

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Wet AMD

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Notal Vision Ltd.: lead

Study Sites (3)

Retina Care specisalists

Palm Beach Gardens, Florida, United States

Location

Elman retina group

Baltimore, Maryland, United States

Location

Pepose Vision Institute

St Louis, Missouri, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Michels, MD

  Retina care specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 13, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: October 3, 2014

Record last verified: 2014-10

Locations

US (3)