Clinical trial NCT00359008: PHP Home Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)
Official title: PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Keywords: AMD
CNV
PHP
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 336
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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

Detailed description: the study is prospective, multi-center, comparative

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

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Ha'emek Hospital
Study officials:
affiliation: Notal Vision
name: Ofer Sharon, MD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1016/j.ophtha.2005.06.008.
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. doi: 10.1097/00006982-200504000-00008.
citation: Bressler NM. Age-related macular degeneration is the leading cause of blindness.. JAMA. 2004 Apr 21;291(15):1900-1. doi: 10.1001/jama.291.15.1900. No abstract available.
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.
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. doi: 10.1001/archopht.1984.01040030942019.