Official Title: “Foresee Home for Monitoring Age Related Macular Degeneration (AMD)”

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.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: December 2010

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.

Intervention(s) in this Clinical Trial

• Device: Foresee Home
  • using the Foresee home device

Arms, Groups and Cohorts in this Clinical Trial

• : Dry AMD
  • Intermediate AMD subjects
• : Wet - treated AMD
  • AMD subjects under treatments

Primary Measures

• To investigate the FORESEE HOME ability to diagnose AMD in different stages
  • Time Frame: 1 year
    Safety Issue?: No

Secondary Measures

• 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).
  • Time Frame: 1 year
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Notal Vision Ltd

Overall Clinical Trial Officials and Contacts

Eliezer Kraus, MD Principal Investigator Naharia Hospital  

Overall Contact: Osnat Ehrman, MSc 972-3-6293763 osnat@notalvision.com

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01010997

Study ID Number: FORESEE HOME- 02

ClinicalTrials.gov Identifier: NCT01010997

Health Authority: Israel: Ministry of Health