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

Age Related Macular Degeneration Clinical Trial

— CNV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334294
• Other study ID #: PT US 001.2
• Status: Completed
• Phase: N/A
• First received: April 11, 2011
• Last updated: October 2, 2014
• Start date: April 2011
• Est. completion date: March 2014

Study information

• Verified date: October 2014
• Source: Notal Vision Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

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.

Locations

Country	Name	City	State
United States	Elman retina group	Baltimore	Maryland
United States	Retina Care specisalists	Palm Beach Gardens	Florida
United States	Pepose Vision Institute	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the accuracy of the ForeseeHome to detect reactivation of CNV following successful treatment with Anti-VEGF		1 year	No
Secondary	Evaluate the correlation between PHP measures and OCT measures		1 year	No