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

NCT ID: NCT01334294

Last Updated: 2014-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-03-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1. Received therapy for CNV

ForeseeHome

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Notal Vision Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Michels, MD

Role: PRINCIPAL_INVESTIGATOR

Retina care specialists

Locations

Retina Care specisalists

Palm Beach Gardens, Florida, United States

Elman retina group

Baltimore, Maryland, United States

Pepose Vision Institute

St Louis, Missouri, United States

Countries

United States

Other Identifiers

PT US 001.2

Identifier Type: -

Identifier Source: org_study_id