PreView PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

This study has been completed.

First Received: July 27, 2006 Last Updated: January 10, 2008 History of Changes

Sponsored by:	Notal Vision Ltd
Information provided by:	Notal Vision Ltd
ClinicalTrials.gov Identifier:	NCT00358345

Purpose

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.

Condition	Phase
Age Related Macular Degeneration	Phase IV

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

Further study details as provided by Notal Vision Ltd:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	347
Study Start Date:	October 2003
Study Completion Date:	September 2007

Groups/Cohorts
1 Intermediate AMD
2 Newly diagnosed CNV

Detailed Description:

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

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358345

Locations

Israel
Tel Aviv Sourasky medical center
Tel Aviv, Israel

Sponsors and Collaborators

Notal Vision Ltd

Investigators

Study Director:

Ofer Sharon, MD

Notal Vision

More Information

No publications provided

Responsible Party:	NotalVision ( Osnat Ehrman )
Study ID Numbers:	PHP C9
Study First Received:	July 27, 2006
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00358345 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Notal Vision Ltd:

AMD

Study placed in the following topic categories:

Metaplasia
Eye Diseases
Choroid Diseases
Retinal Degeneration

Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes
Metaplasia
Eye Diseases
Choroid Diseases

Retinal Degeneration
Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

ClinicalTrials.gov processed this record on May 07, 2009