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Correlation Between Visual Field Defects on Foresee Preferential Hyperacuity Perimeter(PHP) and on Optical Coherence Tomography (OCT) in Patients With Choroidal Neovascularization (CNV)

Sponsor
Notal Vision Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT00692887
Collaborator
(none)
15
Enrollment
1
Location
7
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study come to investigate the correlation between visual fields (VF) defects map generated by preferential hyperacuity perimeter (PHP) and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT).

To investigate the Foresee PHP ability to asses treatment progression post treatment.

Condition or Disease Intervention/Treatment Phase
  • Device: PHP - Preferential Hyperacuity Perimeter (Foresee)

Detailed Description

The Foresee PHP is used in the recent years to detect Age-related Macular Degeneration (AMD) lesions. The device is capable of differentiation as to stages of AMD and early detection of changes including choroidal neovascularization (CNV) The Foresee PHP™ demonstrates a high level of sensitivity and specificity as to the different stages of AMD including newly diagnosed or early detection of CNV.

The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.

The Foresee PHP can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.

Study Design

Study Type:
Observational
Actual Enrollment :
15 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Correlation Between Visual Field Defects on Foresee PHP and OCT in Patients With CNV Before and After Treatment
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Jan 1, 2009

Arms and Interventions

Arm Intervention/Treatment
1

Subjects diagnosed as new CNV or treated CNV

Device: PHP - Preferential Hyperacuity Perimeter (Foresee)
computerized test
Other Names:
  • PHP 2.0.5
  • OCT - optical coherence tomography

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To investigate the correlation between visual fields (VF) defects map generated by preferential hyperacuity perimeter (PHP) and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT). [6 month]

    Secondary Outcome Measures

    1. To investigate the Foresee PHP ability to asses treatment progression post treatment. [6 month]

    Eligibility Criteria

    Criteria

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

    • Capable and willing to sign a consent form and participate in the study

    • Subjects diagnosed as new CNV or treated CNV

    • Age >50 years

    • VA with habitual correction <20/160 in the study eye

    • Ability to understand instructions

    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 in the study eye by biomicroscopy,

    • Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye

    • Patients diagnosed with geographic atrophy (GA)

    • Participation in another study with the exclusion of AREDS study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sorasky Medical center Tel Aviv Israel

    Sponsors and Collaborators

    • Notal Vision Ltd.

    Investigators

    • Principal Investigator: Anat Loewenstein, Prof., Sorasky Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00692887
    Other Study ID Numbers:
    • PHP-POST-01
    First Posted:
    Jun 6, 2008
    Last Update Posted:
    Jan 28, 2009
    Last Verified:
    Jan 1, 2009
    Keywords provided by , ,
    AMD
    Additional relevant MeSH terms:
    Macular Degeneration

    Study Results

    No Results Posted as of Jan 28, 2009