Sensitivity and Specificity of the Home Macular Perimeter (HMP)
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.
Age Related Macular Degeneration
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Sensitivity and Specificity of the Home Macular Perimeter|
- 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. [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||November 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
newly onset CNV secondary to AMD
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595998
|Meir Medical Center|
|Kfar Saba, Israel|
|Principal Investigator:||Josef Mr Ferenzc, MD||Meir Medical Center|