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

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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.

Study Description
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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

Condition or disease
Age Related Macular Degeneration

Detailed Description:

the study is prospective, multi-center, comparative

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

Study Design
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Study Type : Observational
Actual Enrollment : 336 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)
Study Start Date : July 2006
Actual Study Completion Date : September 2007

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Groups and Cohorts
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Group/Cohort
1
Intermediate AMD
2
New untreated CNV subject


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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 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
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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): NCT00359008


Locations
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Israel
Ha'emek Hospital
Afula, Israel, 18101
Sponsors and Collaborators
Notal Vision Ltd.
Investigators
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Study Director: Ofer Sharon, MD Notal Vision
More Information
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Additional Information:

Publications:

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Responsible Party: Osnat Ehrman, NotalVision
ClinicalTrials.gov Identifier: NCT00359008    
Other Study ID Numbers: PHP V3
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008
Keywords provided by Notal Vision Inc.:
AMD
CNV
PHP
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases