PreView PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00358345

Enrollment

347

Registered

2006-07-31

Start date

2003-10-31

Completion date

2007-09-30

Last updated

2008-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Related Macular Degeneration

Keywords

AMD

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-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.

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Countries

Israel

Outcome results