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

NCT ID: NCT00692887

Last Updated: 2009-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Age Related Macular Degeneration

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Subjects diagnosed as new CNV or treated CNV

PHP - Preferential Hyperacuity Perimeter (Foresee)

Intervention Type DEVICE

computerized test

Interventions

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PHP - Preferential Hyperacuity Perimeter (Foresee)

computerized test

Intervention Type DEVICE

Other Intervention Names

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PHP 2.0.5 OCT - optical coherence tomography

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Notal Vision Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Notal Vision

Principal Investigators

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Anat Loewenstein, Prof.

Role: PRINCIPAL_INVESTIGATOR

Sorasky Medical Center

Locations

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Sorasky Medical center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Related Links

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Other Identifiers

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PHP-POST-01

Identifier Type: -

Identifier Source: org_study_id

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