Usability of the Foresee Home in Intermediate Age Related Macular Degeneration (AMD) Patients

Completed

• Conditions: Age Related Macular Degeneration

• Registration Number: NCT00748384
• Lead Sponsor: Notal Vision Ltd.

Brief Summary

The study purpose is to demonstrate that the target population can receive a packed FORESEE HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them for changes in the visual field with good specificity. And evaluate the device usage on a small scale, at the subjects' homes before a commercial use.

Detailed Description

Numerical output of the FORESEE HOME, output of the usability parameters provided by the FORESEE HOME device, counts of the number of subjects who successfully set up the device and conduct testing sessions.

Study Timeline

• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-05
• Study First Posted: 2008-09-08
• Study Start: 2009-02
• Primary Completion: 2013-03
• Status Verified: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-14
• Last Update Posted: 2013-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Capable and willing to sign a consent form and participate in the study

  • Subjects diagnosed as intermediate AMD in at least one eye (in case a patient will convert during the study period he will be excluded)
  • Age more than 50 years
  • VA with habitual correction better than 20/60 in the study eye
  • Ability to speak, read and understand instructions in English or Hebrew
  • Familiar with computer usage

Exclusion Criteria

• Evidence of macular disease other than AMD or glaucoma in the study eye

  • Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP.
  • Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
  • Never been tested on the PHP device
  • Participation in another study with the exclusion of AREDS study
  • Patients diagnosed with geographic atrophy (GA)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who managed to set the device	6 months
Proportion of subjects who managed to perform the test after dynamic tutorial/supervised training	6 month
Number of device malfunctions	6 month
Average use of the device	6 month

Trial Locations

Locations (2)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel

Kaplan Medical Center; 🇮🇱 Rechovot, Israel