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

• ClinicalTrials.gov Identifier: NCT00359008
• Recruitment Status: Completed
• First Posted: August 1, 2006
• Last Update Posted: January 15, 2008
• Sponsor: Notal Vision Ltd.
• Information provided by: Notal Vision Inc.

Tracking Information

• First Submitted Date: July 30, 2006
• First Posted Date: August 1, 2006
• Last Update Posted Date: January 15, 2008
• Study Start Date: July 2006
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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 )

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Age Related Macular Degeneration
• Intervention: Not Provided

Study Groups/Cohorts

• 1
  Intermediate AMD
• 2
  New untreated CNV subject

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 3, 2007): 336
• Original Enrollment (submitted: July 30, 2006): 400
• Actual Study Completion Date: September 2007
• Primary Completion Date: Not Provided

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00359008
• Other Study ID Numbers: PHP V3
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Osnat Ehrman, NotalVision
• Study Sponsor: Notal Vision Ltd.
• Collaborators: Not Provided

Investigators

• Study Director: Ofer Sharon, MD; Notal Vision

• PRS Account: Notal Vision Inc.
• Verification Date: January 2008