PreView PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

Notal Vision Ltd.347 enrolled

Overview

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-related Macular Degeneration (AMD) or Myopia and differentiate them from Intermediate AMD or Geographic Atrophy (GA)or patients with high Myopia with no CNV. This study secondary is to enhance NotalVision normative database.

* The study is prospective, multi-center, comparative study. * A clinical trail with FDA approval device (510K).

Study Type

OBSERVATIONAL

Enrollment

347

Conditions

Age Related Macular Degeneration

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Locations (1)

Tel Aviv Sourasky medical center

Tel Aviv, Israel

Data from ClinicalTrials.gov

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