PreView PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

January 10, 2008 updated by: Notal Vision Ltd.

PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

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.

Study Overview

Status

Completed

Conditions

Age Related Macular Degeneration

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

347

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Tel Aviv, Israel
    - Tel Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

At least 200 subjects with intermediate AMD in at least one (1) eye based on medical record review and/or clinical diagnosis and at least 200 subjects with neovascular AMD in at least one (1) eye.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 Intermediate AMD
2 Newly diagnosed CNV

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Notal Vision Ltd.

Investigators

Study Director: Ofer Sharon, MD, Notal Vision

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

July 27, 2006

First Submitted That Met QC Criteria