PreView PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

This study has been completed.
Sponsor:
Information provided by:
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT00358345
First received: July 27, 2006
Last updated: January 10, 2008
Last verified: January 2008
  Purpose

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 Phase
Age Related Macular Degeneration
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

Resource links provided by NLM:


Further study details as provided by Notal Vision Ltd:

Enrollment: 347
Study Start Date: October 2003
Study Completion Date: September 2007
Groups/Cohorts
1
Intermediate AMD
2
Newly diagnosed CNV

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

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.
  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: 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
  More Information

No publications provided

Responsible Party: Osnat Ehrman, NotalVision
ClinicalTrials.gov Identifier: NCT00358345     History of Changes
Other Study ID Numbers: PHP C9
Study First Received: July 27, 2006
Last Updated: January 10, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on July 22, 2014