Clinical trial NCT00692887: Correlation Between Visual Field Defects on Foresee Preferential Hyperacuity Perimeter(PHP) and on Optical Coherence Tomography (OCT) in Patients With Choroidal Neovascularization (CNV)
Official title: Correlation Between Visual Field Defects on Foresee PHP and OCT in Patients With CNV Before and After Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Keywords: AMD
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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 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

Primary outcomes:
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).
timeFrame: 6 month
Secondary outcomes:
measure: To investigate the Foresee PHP ability to asses treatment progression post treatment.
timeFrame: 6 month
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sorasky Medical center
Study officials:
affiliation: Sorasky Medical Center
name: Anat Loewenstein, Prof.
role: PRINCIPAL_INVESTIGATOR
References: