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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT01073592
First received: February 22, 2010
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Age Related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Between Home Macular Perimeter (FORESEE HOME) and OCT Visual Field Defects in Patients With CNV

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:
  • Size and location of lesions [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2009
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
CNV patiens

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects suspected to have CNV secondary to AMD in at least one eye

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073592

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

Additional Information:
sponsor web site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Notal Vision Ltd
ClinicalTrials.gov Identifier: NCT01073592     History of Changes
Other Study ID Numbers: FORESEE HOME-POST-03
Study First Received: February 22, 2010
Last Updated: May 16, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Notal Vision Ltd:
HMP
CNV
AMD
 PHP
HPHP
FORESEE HOME

Additional relevant MeSH terms:
Macular Degeneration
Scotoma
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Vision Disorders
Sensation Disorders
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013