PHP Home Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)
Completed
- Conditions
- Age Related Macular Degeneration
- Registration Number
- NCT00359008
- Lead Sponsor
- Notal Vision Ltd.
- 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 Macular Degeneration (AMD) and differentiate them from Early/intermediate/GA AMD
- Detailed Description
the study is prospective, multi-center, comparative
The PHP is a class I FDA approved Device ( K050350 )
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 336
Inclusion Criteria
- 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 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 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ha'emek Hospital
🇮🇱Afula, Israel