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

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 3


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Further study details as provided by Notal Vision Ltd:


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional 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.

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

Keywords provided by Notal Vision Ltd:


AMD CNV PHP

Additional relevant MeSH terms:


Choroidal Neovascularization Macular Degeneration Choroid Diseases Eye Diseases Metaplasia	Neovascularization, Pathologic Pathologic Processes Retinal Degeneration Retinal Diseases Uveal Diseases

ClinicalTrials.gov processed this record on February 27, 2015