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

Age Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884637
• Other study ID #: FORESEE HOME-POST-01
• Status: Completed
• Phase: N/A
• First received: April 20, 2009
• Last updated: October 2, 2014
• Start date: June 2009
• Est. completion date: March 2014

Study information

• Verified date: October 2014
• Source: Notal Vision Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• 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 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration

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	Size and location of lesions		6 months	No

External Links

•   Sponsor site