Foresee Home for Monitoring Age Related Macular Degeneration (AMD)
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Purpose
The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.
| Condition | Intervention |
|---|---|
|
Age Related Macular Degeneration |
Device: Foresee Home |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Foresee Home for Monitoring Age Related Macular Degeneration (AMD) |
- To investigate the FORESEE HOME ability to diagnose AMD in different stages [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To investigate the correlation between visual fields (VF) defects map generated by the FORESEE HOME and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | December 2009 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Dry AMD
Intermediate AMD subjects
|
Device: Foresee Home
using the Foresee home device
|
|
Wet - treated AMD
AMD subjects under treatments
|
Device: Foresee Home
using the Foresee home device
|
Detailed Description:
The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
AMD subjects
Inclusion Criteria:
- Capable and willing to sign a consent form and participate in the study
- Subjects diagnosed as CNV under treatment or Intermediate AMD in at least one eye
- Did not perform more then 10 anti- VEGF injections
- Age >50 years
- VA with habitual correction >6/45 in the study eye
- Computer users
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Notal Vision Ltd |
| ClinicalTrials.gov Identifier: | NCT01010997 History of Changes |
| Other Study ID Numbers: | FORESEE HOME- 02, 75909 |
| Study First Received: | November 8, 2009 |
| Last Updated: | July 30, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Notal Vision Ltd:
|
AMD, CNV |
Additional relevant MeSH terms:
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 22, 2013