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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT01334294
First received: April 11, 2011
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  Purpose

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).


Condition Intervention
Age Related Macular Degeneration
Choroidal Neovascularization
 Device: ForeseeHome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Home Vision Monitoring Using the ForeseeHome Device Following Treatment of Neovascular AMD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:
  • Assess the accuracy of the ForeseeHome to detect reactivation of CNV following successful treatment with Anti-VEGF [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the correlation between PHP measures and OCT measures [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1. Received therapy for CNV 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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Wet AMD

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334294

Locations
United States, Florida
Retina Care specisalists
Palm Beach Gardens, Florida, United States
United States, Maryland
Elman retina group
Baltimore, Maryland, United States
United States, Missouri
Pepose Vision Institute
St. Louis, Missouri, United States
Sponsors and Collaborators
Notal Vision Ltd
Investigators
Principal Investigator: Mark Michels, MD Retina care specialists
  More Information

No publications provided

Responsible Party: Notal Vision Ltd
ClinicalTrials.gov Identifier: NCT01334294     History of Changes
Other Study ID Numbers: PT US 001.2
Study First Received: April 11, 2011
Last Updated: July 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Notal Vision Ltd:
CNV
AMD

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Wet Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on May 16, 2013