Status:
COMPLETED
Usability of the Foresee Home in Intermediate Age Related Macular Degeneration (AMD) Patients
Lead Sponsor:
Notal Vision Ltd.
Conditions:
Age Related Macular Degeneration
Eligibility:
All Genders
50+ years
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 th...
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 se...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00748384
Start Date
February 1 2009
End Date
May 1 2013
Last Update
May 15 2013
Active Locations (2)
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1
Meir Medical Center
Kfar Saba, Israel
2
Kaplan Medical Center
Rehovot, Israel