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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
History of Changes
  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:

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
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:

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 May 21, 2013