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

May 26, 2008
January 27, 2009
June 2008
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00692887 on ClinicalTrials.gov Archive Site
To investigate the Foresee PHP ability to asses treatment progression post treatment. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Correlation Between Visual Field Defects on Foresee Preferential Hyperacuity Perimeter(PHP) and on Optical Coherence Tomography (OCT) in Patients With Choroidal Neovascularization (CNV)
Correlation Between Visual Field Defects on Foresee PHP and OCT in Patients With CNV Before and After Treatment

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
  • Subjects diagnosed as new CNV or treated CNV
  • Age >50 years
  • VA with habitual correction <20/160 in the study eye
Age Related Macular Degeneration
Device: PHP - Preferential Hyperacuity Perimeter (Foresee)
computerized test
Other Names:
  • PHP 2.0.5
  • OCT - optical coherence tomography
1
Subjects diagnosed as new CNV or treated CNV
Intervention: Device: PHP - Preferential Hyperacuity Perimeter (Foresee)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
January 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00692887
PHP-POST-01
Yes
Osnat Ehrman, Notal Vision
Notal Vision Ltd
Not Provided
Principal Investigator: Anat Loewenstein, Prof. Sorasky Medical Center
Notal Vision Ltd
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP