Comparison Between Foresee Home and Optical Coherence Tomography (OCT) Visual Field Defects in Patients With Choroidal Neovascularization (CNV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01073592
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : May 17, 2013
Information provided by (Responsible Party):
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.

Condition or disease
Age Related Macular Degeneration

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Between Home Macular Perimeter (FORESEE HOME) and OCT Visual Field Defects in Patients With CNV
Study Start Date : August 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

CNV patiens

Primary Outcome Measures :
  1. Size and location of lesions [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects suspected to have CNV secondary to AMD in at least one eye

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01073592

Rabin Medical Center
Petach Tikva, Israel
Sponsors and Collaborators
Notal Vision Ltd
Principal Investigator: Ruth Siegal, Prof. Rabin Medical Center

Additional Information:
Responsible Party: Notal Vision Ltd Identifier: NCT01073592     History of Changes
Other Study ID Numbers: FORESEE HOME-POST-03
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: May 2013

Keywords provided by Notal Vision Ltd:

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Pathologic Processes