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PreView PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

Sponsor
Notal Vision Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT00358345
Collaborator
(none)
347
Enrollment
1
Location
47
Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to assess the ability of the PreView PHP(study device)to detect newly diagnosed non-treated Choroidal Neovascularization (CNV)lesion associate with advanced Age-related Macular Degeneration (AMD) or Myopia and differentiate them from Intermediate AMD or Geographic Atrophy (GA)or patients with high Myopia with no CNV.

This study secondary is to enhance NotalVision normative database.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    • The study is prospective, multi-center, comparative study.

    • A clinical trail with FDA approval device (510K).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    347 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization
    Study Start Date :
    Oct 1, 2003
    Actual Study Completion Date :
    Sep 1, 2007

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Intermediate AMD
    2

    Newly diagnosed CNV

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      50 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Newly diagnosed (up yo 2 months) CNV OR Intermediate AMD

      • Age >50 for AMD subjects

      • Age >18 for Myopic subjects

      • VA 20/160 or better in the study eye

      • Mental and physical ability to performed a PHP test

      Exclusion Criteria:

      • Evidence of macular disease other than AMD or high myopia in the study eye.

      • Previous surgical or laser treatment within the macular erea.

      • Concurrent intraocular drug therapy (within 30 days).

      • Present of any significant media opacity that preclude a clear veiw of the macula.

      • Any non macular related ocular surgery performed within 3 months prior to the study.

      • CNV subjects inability to tolerate intravenous fluorscien angiography.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Tel Aviv Sourasky medical center Tel Aviv Israel

      Sponsors and Collaborators

      • Notal Vision Ltd.

      Investigators

      • Study Director: Ofer Sharon, MD, Notal Vision

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00358345
      Other Study ID Numbers:
      • PHP C9
      First Posted:
      Jul 31, 2006
      Last Update Posted:
      Jan 15, 2008
      Last Verified:
      Jan 1, 2008
      Keywords provided by , ,
      AMD
      Additional relevant MeSH terms:
      Macular Degeneration
      Choroidal Neovascularization
      Neovascularization, Pathologic

      Study Results

      No Results Posted as of Jan 15, 2008