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Sponsored by: |
Notal Vision Ltd |
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Information provided by: | Notal Vision Ltd |
ClinicalTrials.gov Identifier: | NCT00748384 |
The study purpose is to demonstrate that the target population can receive a packed FORESEE HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them for changes in the visual field with good specificity. And evaluate the device usage on a small scale, at the subjects' homes before a commercial use.
Condition |
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Age Related Macular Degeneration |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Usability of the Foresee Home in Intermediate Age Related Macular Degeneration Patients |
Estimated Enrollment: | 50 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Self trained subjects
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2
supervised trained subjects
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Numerical output of the FORESEE HOME, output of the usability parameters provided by the FORESEE HOME device, counts of the number of subjects who successfully set up the device and conduct testing sessions.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Subjects diagnosed as Intermediate AMD
Inclusion Criteria:
Capable and willing to sign a consent form and participate in the study
Exclusion Criteria:
Evidence of macular disease other than AMD or glaucoma in the study eye
Contact: Osnat Ehrman, M.Sc. | +972 3 6293763 ext 117 | osnat@notalvision.com |
Israel | |
Kaplan Medical Center | Recruiting |
Rechovot, Israel | |
Contact: Haya Katz, M.D. 972 8 9441354 | |
Meir Medical Center | Recruiting |
Kfar Saba, Israel | |
Contact: Josef Ferencz, M.D. |
Principal Investigator: | Haya Morori Katz, M.D. | Kaplan Medical Center |
Responsible Party: | Notal Vision LTD ( Osnat Ehrman ) |
Study ID Numbers: | HMP-UU2 |
Study First Received: | September 4, 2008 |
Last Updated: | April 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00748384 History of Changes |
Health Authority: | Israel: Ministry of Health |
HMP, CNV, AMD, PHP, HPHP, foresee |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |