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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00359008
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : January 15, 2008
Sponsor:
Information provided by:
Notal Vision Inc.

Tracking Information
First Submitted Date July 30, 2006
First Posted Date August 1, 2006
Last Update Posted Date January 15, 2008
Study Start Date July 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PHP Home Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)
Official Title PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)
Brief Summary 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
Detailed Description

the study is prospective, multi-center, comparative

The PHP is a class I FDA approved Device ( K050350 )

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Age Related Macular Degeneration
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Intermediate AMD
  • 2
    New untreated CNV subject
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 3, 2007)
336
Original Enrollment
 (submitted: July 30, 2006)
400
Actual Study Completion Date September 2007
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00359008
Other Study ID Numbers PHP V3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Osnat Ehrman, NotalVision
Study Sponsor Notal Vision Ltd.
Collaborators Not Provided
Investigators
Study Director: Ofer Sharon, MD Notal Vision
PRS Account Notal Vision Inc.
Verification Date January 2008