Correlation Between Visual Field Defects on FORESEE HOME and on Optical Coherence Tomography in Choroidal Neovascularization Subjects

This study is not yet open for participant recruitment.

Verified by Notal Vision Ltd, June 2009

First Received: April 20, 2009 Last Updated: June 2, 2009 History of Changes

Sponsored by:	Notal Vision Ltd
Information provided by:	Notal Vision Ltd
ClinicalTrials.gov Identifier:	NCT00884637

Purpose

The FORESEE HOME 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 HOME 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 HOME 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.

Condition
Age Related Macular Degeneration

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Correlation Between Visual Field Defects on Home Macular Perimeter (FORESEE HOME) and on OCT in Eyes of Patients With CNV Before and After Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:

Size and location of lesions [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	June 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
CNV subjects

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 suspected to have CNV secondary to AMD in at least one eye

Criteria

Inclusion Criteria:

Capable and willing to sign a consent form and participate in the study
Subjects diagnosed with CNV
Did not perform more then 4 anti- VGEF injections
VA with habitual correction better then 6/45 in the study eye
Ability to understand instructions
Familiar with computer usage

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
Participation in another study with the exclusion of AREDS study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884637

Contacts

Contact: Osnat Ehrman, M.Sc.

+972 3 6293763 ext 117

osnat@notalvision.com

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

Additional Information:

Sponsor site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Notal Vision ( Osnat Ehrman )
Study ID Numbers:	FORESEE HOME-POST-01
Study First Received:	April 20, 2009
Last Updated:	June 2, 2009
ClinicalTrials.gov Identifier:	NCT00884637 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Notal Vision Ltd:

HMP
CNV
AMD

PHP
HPHP
foresee home

Study placed in the following topic categories:

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

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

Additional relevant MeSH terms:

Sensation Disorders
Uveal Diseases
Vision Disorders
Eye Diseases
Nervous System Diseases
Choroid Diseases
Macular Degeneration
Retinal Degeneration

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

ClinicalTrials.gov processed this record on August 24, 2009