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

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Device: PHP - Preferential Hyperacuity Perimeter (Foresee)

• Registration Number: NCT00692887
• Lead Sponsor: Notal Vision Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2008-05-26
• Study Start: 2008-06
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2008-12
• Status Verified: 2009-01
• Study Completion: 2009-01
• Last Update Submitted: 2009-01-27
• Last Update Posted: 2009-01-28

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 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	PHP - Preferential Hyperacuity Perimeter (Foresee)	Subjects diagnosed as new CNV or treated CNV

Primary Outcome Measures

Name	Time	Method
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).	6 month

Secondary Outcome Measures

Name	Time	Method
To investigate the Foresee PHP ability to asses treatment progression post treatment.	6 month

Trial Locations

Locations (1)

Sorasky Medical center; 🇮🇱 Tel Aviv, Israel