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

NCT00884637 | Completed

• 1 other identifier: FORESEE HOME-POST-01
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Age Related Macular Degeneration

Keywords

HMP; CNV; AMD; PHP; HPHP; foresee home

Outcome Measures

Primary Outcomes (1)

• Size and location of lesions

  6 months

Study Arms (1)

CNV subjects

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects suspected to have CNV secondary to AMD in at least one eye

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Notal Vision Ltd.: lead

Study Sites (1)

Sorasky Medical Center

Tel Aviv, Israel

Location

Related Links

• Sponsor site

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Anat Loewenstein, Prof.

  Sorasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 21, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: October 3, 2014

Record last verified: 2014-10

Locations

IL (1)