Foresee Home for Monitoring Age Related Macular Degeneration (AMD)

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Device: Foresee Home

• Registration Number: NCT01010997
• Lead Sponsor: Notal Vision Ltd.

Brief Summary

The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.

Detailed Description

The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.

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.

Study Timeline

• Study First Submitted: 2009-11-08
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Study Start: 2009-12
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-30
• Last Update Posted: 2012-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Capable and willing to sign a consent form and participate in the study
• Subjects diagnosed as CNV under treatment or Intermediate AMD in at least one eye
• Did not perform more then 10 anti- VEGF injections
• Age >50 years
• VA with habitual correction >6/45 in the study eye
• Computer users

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dry AMD	Foresee Home	Intermediate AMD subjects
Wet - treated AMD	Foresee Home	AMD subjects under treatments

Primary Outcome Measures

Name	Time	Method
To investigate the FORESEE HOME ability to diagnose AMD in different stages	1 year

Secondary Outcome Measures

Name	Time	Method
To investigate the correlation between visual fields (VF) defects map generated by the FORESEE HOME and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT).	1 year

Trial Locations

Locations (1)

Naharia Hospital; 🇮🇱 Naharia, Israel