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| Sponsored by: |
Notal Vision Ltd |
|---|---|
| Information provided by: | Notal Vision Ltd |
| ClinicalTrials.gov Identifier: | NCT00595998 |
Purpose
The primary objective of this study is to estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD, and differentiate them from intermediate AMD subjects.
| Condition |
|---|
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Age Related Macular Degeneration |
| Study Type: | Observational |
| Study Design: | Cohort, Retrospective |
| Official Title: | Sensitivity and Specificity of the Home Macular Perimeter |
| Enrollment: | 42 |
| Study Start Date: | January 2008 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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1
newly onset CNV secondary to AMD
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|
2
Intermediate AMD
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It is a one encounter visit in which patients are enrolled and complete the study on the same day. This will allow recruiting and testing of patients with CNV which is a dynamic disease that is most often treated on that same day. Following enrollment, patients will go through an examiner supervised tutorial followed by a self-performed HMP examination. In addition patient will undergo an Amsler grid examination, biomicroscopy, color fundus photography and fluorescein angiography. The HMP output shall be a test result that can be within or outside normal limits. Inherent to the test are reliability criteria which help to determine if the patient performed the test reliably. These consist of false positive and false negative errors. All criteria for normal limits and reliable performance are set prior to study initiation. The outcome measures for the study are the sensitivity in identifying visual functional defects in patients with CNV.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
The study population will include 30 subjects suspected to have newly onset CNV secondary to AMD in at least one eye, or Intermediate AMD in at least one eye, and who consent to participate in the study.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Meir Medical center ( Dr. Josef Ferenzc ) |
| Study ID Numbers: | HMP-SS1, MMC-0206-07 |
| Study First Received: | January 6, 2008 |
| Last Updated: | January 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00595998 History of Changes |
| Health Authority: | Israel: Ministry of Health |
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AMD, HMP, PHP |
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Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |
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Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |