Correlation Between Visual Field Defects on FORESEE HOME and on Optical Coherence Tomography in Choroidal Neovascularization Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT00884637
First received: April 20, 2009
Last updated: May 14, 2013
Last verified: May 2013
  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: Correlation Between Visual Field Defects on Home Macular Perimeter (FORESEE HOME) and on OCT in Eyes of Patients With CNV Before and After Treatment

Resource links provided by NLM:


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 ]

Estimated Enrollment: 50
Study Start Date: June 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
CNV subjects

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884637

Locations
Israel
Sorasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Notal Vision Ltd
Investigators
Principal Investigator: Anat Loewenstein, Prof. Sorasky Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Notal Vision Ltd
ClinicalTrials.gov Identifier: NCT00884637     History of Changes
Other Study ID Numbers: FORESEE HOME-POST-01
Study First Received: April 20, 2009
Last Updated: May 14, 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 July 28, 2014