PHP Home Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)

Age Related Macular Degeneration Clinical Trial

Official title:

PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359008
• Other study ID #: PHP V3
• Status: Completed
• Phase: Phase 3
• First received: July 30, 2006
• Last updated: January 10, 2008
• Start date: July 2006
• 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 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

Description:

the study is prospective, multi-center, comparative

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

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	Ha'emek Hospital	Afula

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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. — View Citation

Bressler NM. Age-related macular degeneration is the leading cause of blindness... JAMA. 2004 Apr 21;291(15):1900-1. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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