- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00692887
Correlation Between Visual Field Defects on Foresee Preferential Hyperacuity Perimeter(PHP) and on Optical Coherence Tomography (OCT) in Patients With Choroidal Neovascularization (CNV) (PHP)
Correlation Between Visual Field Defects on Foresee PHP and OCT in Patients With CNV Before and After Treatment
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Tel Aviv, Israel
- Sorasky Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Subjects diagnosed as new CNV or treated CNV
- Age >50 years
- VA with habitual correction <20/160 in the study eye
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Subjects diagnosed as new CNV or treated CNV
|
computerized test
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To investigate the Foresee PHP ability to asses treatment progression post treatment.
Time Frame: 6 month
|
6 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anat Loewenstein, Prof., Sorasky Medical Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHP-POST-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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