Correlation Between Visual Field Defects on Foresee Preferential Hyperacuity Perimeter(PHP) and on Optical Coherence Tomography (OCT) in Patients With Choroidal Neovascularization (CNV)

This study has been completed.
Sponsor:
Information provided by:
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT00692887
First received: May 26, 2008
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

Study come to investigate the correlation between visual fields (VF) defects map generated by preferential hyperacuity perimeter (PHP) and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT).

To investigate the Foresee PHP ability to asses treatment progression post treatment.


Condition Intervention
Age Related Macular Degeneration
Device: PHP - Preferential Hyperacuity Perimeter (Foresee)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Correlation Between Visual Field Defects on Foresee PHP and OCT in Patients With CNV Before and After Treatment

Resource links provided by NLM:


Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:
  • To investigate the correlation between visual fields (VF) defects map generated by preferential hyperacuity perimeter (PHP) and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT). [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the Foresee PHP ability to asses treatment progression post treatment. [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: June 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Subjects diagnosed as new CNV or treated CNV
Device: PHP - Preferential Hyperacuity Perimeter (Foresee)
computerized test
Other Names:
  • PHP 2.0.5
  • OCT - optical coherence tomography

Detailed Description:

The Foresee PHP 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 PHP™ 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 PHP 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.

  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 diagnosed as new CNV or treated CNV
  • Age >50 years
  • VA with habitual correction <20/160 in the study eye
Criteria

Inclusion Criteria:

  • Capable and willing to sign a consent form and participate in the study
  • Subjects diagnosed as new CNV or treated CNV
  • Age >50 years
  • VA with habitual correction <20/160 in the study eye
  • Ability to understand instructions

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
  • Patients diagnosed with geographic atrophy (GA)
  • 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: NCT00692887

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: Osnat Ehrman, Notal Vision
ClinicalTrials.gov Identifier: NCT00692887     History of Changes
Other Study ID Numbers: PHP-POST-01
Study First Received: May 26, 2008
Last Updated: January 27, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Notal Vision Ltd:
AMD

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

ClinicalTrials.gov processed this record on October 22, 2014