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

Completed

• Conditions: Age Related Macular Degeneration

• Registration Number: NCT00884637
• Lead Sponsor: Notal Vision Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-21
• Study Start: 2009-06
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-02
• Last Update Posted: 2014-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Size and location of lesions	6 months

Trial Locations

Locations (1)

Sorasky Medical Center; 🇮🇱 Tel Aviv, Israel