Status:
COMPLETED
PreView PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization
Lead Sponsor:
Notal Vision Ltd.
Conditions:
Age Related Macular Degeneration
Eligibility:
All Genders
50+ years
Brief Summary
The primary objective of this study is to assess the ability of the PreView PHP(study device)to detect newly diagnosed non-treated Choroidal Neovascularization (CNV)lesion associate with advanced Age-...
Detailed Description
* The study is prospective, multi-center, comparative study. * A clinical trail with FDA approval device (510K).
Eligibility Criteria
Inclusion
- Newly diagnosed (up yo 2 months) CNV OR Intermediate AMD
- Age \>50 for AMD subjects
- Age \>18 for Myopic subjects
- VA 20/160 or better in the study eye
- Mental and physical ability to performed a PHP test
Exclusion
- Evidence of macular disease other than AMD or high myopia in the study eye.
- Previous surgical or laser treatment within the macular erea.
- Concurrent intraocular drug therapy (within 30 days).
- Present of any significant media opacity that preclude a clear veiw of the macula.
- Any non macular related ocular surgery performed within 3 months prior to the study.
- CNV subjects inability to tolerate intravenous fluorscien angiography.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT00358345
Start Date
October 1 2003
End Date
September 1 2007
Last Update
January 15 2008
Active Locations (1)
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1
Tel Aviv Sourasky medical center
Tel Aviv, Israel