Status:
COMPLETED
PHP Home Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)
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 PHP \& HPHP to detect newly diagnosed non treated Chorodial neovascularization (CNV) lesion associate with advanced age related Macu...
Detailed Description
the study is prospective, multi-center, comparative The PHP is a class I FDA approved Device ( K050350 )
Eligibility Criteria
Inclusion
- Patients with AMD related lesions:
- Newly diagnosed (up to 6 months) non-treated CNV patients secondary to AMD in the study eye, or GA patients or Early and Intermediate AMD patients.
- Age ³ 50 for AMD patients
- VA with habitual correction in study eye 6/60 or better
- Mental and physical ability to perform a PHP/HPHP test
- Subject able and willing to sign consent form and participate in study
- Subject is not participating in another study when conducting the test
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 by biomicroscopy, fundus photography, or fluorescein angiography in the study eye
- Any non-macular related ocular surgery performed within 3 months prior to the study in the study eye
- CNV patient inability to tolerate intravenous fluorescein angiography
Key Trial Info
Start Date :
July 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT00359008
Start Date
July 1 2006
End Date
September 1 2007
Last Update
January 15 2008
Active Locations (1)
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1
Ha'emek Hospital
Afula, Israel, 18101