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Sponsored by: |
Notal Vision Ltd |
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Information provided by: | Notal Vision Ltd |
ClinicalTrials.gov Identifier: | NCT00592826 |
The study is divided in two stages. The purpose of the first stage is to evaluate the percentage of subjects that can unpack the device, install it, learn the task and calibrate it according to their personal capabilities. The purpose of the second stage is to assess the ability of the subjects to perform reliable tests .
Condition |
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Age Related Macular Degeneration |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Phase III Study of the Usability of the HMP Device |
Enrollment: | 25 |
Study Start Date: | November 2007 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Stage I:
This stage will be completed within 1 to 5 visits, depending on personal progress rate.
Subjects who have successfully completed stage I will be recruited to stage II.
Those subjects will:
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Subjects will be recruited in community centers and clinics and will include up to 25 people aged >50 years (Age-related Macular Degeneration age group). The group will be heterogeneous in terms of education, age, ethnic background, and gender. The subjects will be enrolled in one site in the USA In order to get 20 completed subjects, and based of assumption of 25% attrition- 25 subjects will be recruited to the study
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Notal Vision ( Osnat Ehrman - Clinical Manager ) |
Study ID Numbers: | T3, WIRB Pr. No.: 20071980 |
Study First Received: | January 1, 2008 |
Last Updated: | May 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00592826 History of Changes |
Health Authority: | United States: Institutional Review Board |
PHP HMP HPHP AMD CNV |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |