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

This study has been completed.
Sponsor:
Information provided by:
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT00359008
First received: July 30, 2006
Last updated: January 10, 2008
Last verified: January 2008
  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:


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

ClinicalTrials.gov processed this record on July 22, 2014