PHP Home Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV) - Full Text View

Sponsored by:	Notal Vision Ltd
Information provided by:	Notal Vision Ltd
ClinicalTrials.gov Identifier:	NCT00359008

Purpose

The primary objective of this study is to assess the ability of the PHP & HPHP to detect newly diagnosed non treated Chorodial neovascularization (CNV) lesion associate with advanced age related Macular Degeneration (AMD) and differentiate them from Early/intermediate/GA AMD

Condition	Phase
Age Related Macular Degeneration	Phase III

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 (CNV)

Further study details as provided by Notal Vision Ltd:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	336
Study Start Date:	July 2006
Study Completion Date:	September 2007

Groups/Cohorts
1 Intermediate AMD
2 New untreated CNV subject

Detailed Description:

the study is prospective, multi-center, comparative

The PHP is a class I FDA approved Device ( K050350 )

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 in all sites.

Criteria

Inclusion Criteria:

Patients with AMD related lesions:

Newly diagnosed (up to 6 months) non-treated CNV patients secondary to AMD in the study eye, or GA patients or Early and Intermediate AMD patients.

Age ³ 50 for AMD patients
VA with habitual correction in study eye 6/60 or better
Mental and physical ability to perform a PHP/HPHP test
Subject able and willing to sign consent form and participate in study
Subject is not participating in another study when conducting the test

Exclusion Criteria:

Evidence of macular disease other than AMD or Glaucoma in the study eye.
- Presence of any significant media opacity that precludes a clear view of the macular area as identified by biomicroscopy, fundus photography, or fluorescein angiography in the study eye
- Any non-macular related ocular surgery performed within 3 months prior to the study in the study eye
- CNV patient inability to tolerate intravenous fluorescein angiography

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359008

Locations

Israel
Ha'emek Hospital
Afula, Israel, 18101

Sponsors and Collaborators

Notal Vision Ltd

Investigators

Study Director:

Ofer Sharon, MD

Notal Vision

More Information

Company Site This link exits the ClinicalTrials.gov site

Publications:

Alster Y, Bressler NM, Bressler SB, Brimacombe JA, Crompton RM, Duh YJ, Gabel VP, Heier JS, Ip MS, Loewenstein A, Packo KH, Stur M, Toaff T; Preferential Hyperacuity Perimetry Research Group. Preferential Hyperacuity Perimeter (PreView PHP) for detecting choroidal neovascularization study. Ophthalmology. 2005 Oct;112(10):1758-65.

Goldstein M, Loewenstein A, Barak A, Pollack A, Bukelman A, Katz H, Springer A, Schachat AP, Bressler NM, Bressler SB, Cooney MJ, Alster Y, Rafaeli O, Malach R; Preferential Hyperacuity Perimeter Research Group. Results of a multicenter clinical trial to evaluate the preferential hyperacuity perimeter for detection of age-related macular degeneration. Retina. 2005 Apr-May;25(3):296-303.

Bressler NM. Age-related macular degeneration is the leading cause of blindness... JAMA. 2004 Apr 21;291(15):1900-1. No abstract available.

Bressler NM. Early detection and treatment of neovascular age-related macular degeneration. J Am Board Fam Pract. 2002 Mar-Apr;15(2):142-52. Review.

Enoch JM, Williams RA, Essock EA, Barricks M. Hyperacuity perimetry. Assessment of macular function through ocular opacities. Arch Ophthalmol. 1984 Aug;102(8):1164-8.

Responsible Party:	NotalVision ( Osnat Ehrman )
Study ID Numbers:	PHP V3
Study First Received:	July 30, 2006
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00359008
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Notal Vision Ltd:

AMD
CNV
PHP

Study placed in the following topic categories:

Metaplasia
Eye Diseases
Choroid Diseases
Retinal Degeneration
Macular Degeneration

Neovascularization, Pathologic
Retinal Diseases
Retinal degeneration
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009