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

Age Related Macular Degeneration Clinical Trial

— PHP  

Official title:

Correlation Between Visual Field Defects on Foresee PHP and OCT in Patients With CNV Before and After Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692887
• Other study ID #: PHP-POST-01
• Status: Completed
• Phase: N/A
• First received: May 26, 2008
• Last updated: January 27, 2009
• Start date: June 2008
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: Notal Vision Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration

Intervention

Device:
• PHP - Preferential Hyperacuity Perimeter (Foresee)
computerized test

Locations

Country	Name	City	State
Israel	Sorasky Medical center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		6 month	No
Secondary	To investigate the Foresee PHP ability to asses treatment progression post treatment.		6 month	No

External Links

•   sponsor web site