Correlation Between Visual Field Defects on Foresee PHP and on Optical Coherence Tomography (OCT) in Eyes of Patients With Choroidal Neovascularization (CNV) - Full Text View

Sponsored by:	Notal Vision Ltd
Information provided by:	Notal Vision Ltd
ClinicalTrials.gov Identifier:	NCT00692887

Purpose

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	Intervention
Age Related Macular Degeneration	Device: PHP - Preferential Hyperacuity Perimeter (Foresee)

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Correlation Between Visual Field Defects on Foresee PHP and OCT in Patients With CNV Before and After Treatment

Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To investigate the Foresee PHP ability to asses treatment progression post treatment. [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	June 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Subjects diagnosed as new CNV or treated CNV	Device: PHP - Preferential Hyperacuity Perimeter (Foresee) computerized test

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). Comparisson 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 trated lesions may serve as an additional tool.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692887

Contacts

Contact: Anat Loewnstein, Prof.	972-3-692-5773
Contact: Michael regenbogen, Dr.

Locations

Israel
Sorasky Medical center
Tel Aviv, Israel

Sponsors and Collaborators

Notal Vision Ltd

Investigators

Principal Investigator:

Anat Loewenstein, Prof.

Sorasky Medical Center

More Information

sponsor web site This link exits the ClinicalTrials.gov site

Responsible Party:	Notal Vision ( Osnat Ehrman )
Study ID Numbers:	PHP-POST-01
Study First Received:	May 26, 2008
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00692887
Health Authority:	Israel: Ministry of Health

Keywords provided by Notal Vision Ltd:

AMD

Study placed in the following topic categories:

Sensation Disorders
Vision Disorders
Eye Diseases
Choroid Diseases
Macular Degeneration
Retinal Degeneration
Scotoma

Choroidal Neovascularization
Signs and Symptoms
Metaplasia
Neurologic Manifestations
Neovascularization, Pathologic
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009