Status:
COMPLETED
Usability of the PreView PHP for Home Use in Intermediate AMD Patients
Lead Sponsor:
Notal Vision Ltd.
Conditions:
Age Related Macular Degeneration
Eligibility:
All Genders
65+ years
Brief Summary
To demonstrate the ability of intermediate AMD subjects to follow the instructions for use and properly operate on their own the Preview PHP in home use environment, after going through training sessi...
Detailed Description
The study purpose is to demonstrate that the target population can use the system after going through a supervised training session. The PreView PHP will be operated in the same manner in the simulate...
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
- Age ≥65 years
- VA with habitual correction better than 20/60 in the study eye
- Ability to speak, read and understand instructions in English or Hebrew
- Qualified to use the device by health care professional
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 or macular surgery performed within 3 months prior to study entry in the target eye
- Participation in another study with the exclusion of AREDS study
- Patients diagnosed with geographic atrophy (GA)
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00776451
Start Date
November 1 2008
End Date
March 1 2009
Last Update
June 3 2009
Active Locations (1)
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1
Belinson Medical Center
Petah Tikva, Israel