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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) (PHP)

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ClinicalTrials.gov Identifier: NCT00692887
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : January 28, 2009
Sponsor:
Information provided by:
Notal Vision Inc.

Study Description
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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
Age Related Macular Degeneration 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
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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 : June 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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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). [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. To investigate the Foresee PHP ability to asses treatment progression post treatment. [ Time Frame: 6 month ]

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:   Non-Probability Sample
Study Population
  • Subjects diagnosed as new CNV or treated CNV
  • Age >50 years
  • VA with habitual correction <20/160 in the study eye
Criteria

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
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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): NCT00692887


Locations
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Israel
Sorasky Medical center
Tel Aviv, Israel
Sponsors and Collaborators
Notal Vision Ltd.
Investigators
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Principal Investigator: Anat Loewenstein, Prof. Sorasky Medical Center
More Information
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Additional Information:

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Responsible Party: Osnat Ehrman, Notal Vision
ClinicalTrials.gov Identifier: NCT00692887    
Other Study ID Numbers: PHP-POST-01
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: January 28, 2009
Last Verified: January 2009
Keywords provided by Notal Vision Inc.:
AMD
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases