PreView PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

Age Related Macular Degeneration Clinical Trial

Official title:

PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358345
• Other study ID #: PHP C9
• Status: Completed
• Phase: Phase 4
• First received: July 27, 2006
• Last updated: January 10, 2008
• Start date: October 2003
• Est. completion date: September 2007

Study information

• Verified date: January 2008
• Source: Notal Vision Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

Description:

• The study is prospective, multi-center, comparative study.

• A clinical trail with FDA approval device (510K).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky medical center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd

Country where clinical trial is conducted

Israel,