Correlation Between Visual Field Defects on FORESEE HOME and on Optical Coherence Tomography in Choroidal Neovascularization Subjects
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Purpose
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.
| Condition |
|---|
|
Age Related Macular Degeneration |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- Size and location of lesions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| CNV subjects |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Subjects suspected to have CNV secondary to AMD in at least one eye
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Notal Vision Ltd |
| ClinicalTrials.gov Identifier: | NCT00884637 History of Changes |
| Other Study ID Numbers: | FORESEE HOME-POST-01 |
| Study First Received: | April 20, 2009 |
| Last Updated: | May 14, 2013 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Notal Vision Ltd:
|
HMP CNV AMD |
PHP HPHP foresee home |
Additional relevant MeSH terms:
|
Macular Degeneration Scotoma Choroidal Neovascularization Retinal Degeneration Retinal Diseases Eye Diseases Vision Disorders Sensation Disorders |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms Choroid Diseases Uveal Diseases Neovascularization, Pathologic Metaplasia Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013