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PreView PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

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ClinicalTrials.gov Identifier: NCT00358345
Recruitment Status : Completed
First Posted : July 31, 2006
Last Update Posted : January 15, 2008
Sponsor:
Information provided by:
Notal Vision Ltd

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
Age Related Macular Degeneration

Detailed Description:
  • The study is prospective, multi-center, comparative study.
  • A clinical trail with FDA approval device (510K).

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 : October 2003
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Intermediate AMD
2
Newly diagnosed CNV




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358345


Locations
Israel
Tel Aviv Sourasky medical center
Tel Aviv, Israel
Sponsors and Collaborators
Notal Vision Ltd
Investigators
Study Director: Ofer Sharon, MD Notal Vision

Responsible Party: Osnat Ehrman, NotalVision
ClinicalTrials.gov Identifier: NCT00358345     History of Changes
Other Study ID Numbers: PHP C9
First Posted: July 31, 2006    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008

Keywords provided by Notal Vision Ltd:
AMD

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases