An observational study in Age-related Macular Degeneration, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 60 Years to 95 Years. Per ClinicalTrials.gov, last updated 2019-06-06.
Sponsored by University of Alabama at Birmingham · Observational
Previous work collectively suggests that rod-mediated dark adaptation (RMDA) is a promising candidate as a functional endpoint measure for evaluating interventions to slow early progression of age-related macular degeneration (AMD). However, there is no agreement among the clinical, research and regulatory communities as to what constitutes a clinically (practically) significant slowing in RMDA. Treatments for AMD are often not considered efficacious if they do not result in a criterion level of improvement in vision. But how much change in the rate of dark adaptation constitutes a clinically significant change? Until this issue is resolved, progress in developing clinical trials on early AMD are at a standstill since there is no functional endpoint to be used in the trial. One approach to establishing clinical significance is to examine how RMDA relates to the performance of an everyday visual task under low luminance conditions, such as night driving or reading. However, such data are not yet available. The purpose of this project is to examine the relationship between RMDA and night-time driving and reading under poor illumination. This information will guide the development of a definition of a clinically significant difference in RMDA that can be used in designing clinical trials on early AMD.
The specific aims of this study are as follows:
Aim 1: To examine the association between RMDA as assessed by the rod intercept time and self reported driving difficulty and experiences during night time driving.
Aim 2: To examine the association between RMDA as assessed by rod intercept time and reading performance as assessed by the MNREAD test administered under a low light level. Reading performance will be defined in terms of maximum reading speed, critical print size (i.e., the smallest print size that supports maximum reading speed), reading acuity (i.e., the smallest print size that can be just read) and the reading accessibility index (i.e., an individual's access to text over the range of print sizes found in everyday life).
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 40 is below the median of 106 across 421 observational studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults living in the community who have current driver's license who have age-related macular degeneration
Exclusion Criteria:
rod intercept time
rate of rod-mediated dark adaptation
Time frame: measured once (1 day)
severity of age-related macular degeneration
defined by grading of color fundus photos
Time frame: measured once (1 day)
Plan to share: Undecided — Once study is completed and published in the peer review literature, we will arrange for a data sharing process with other researchers
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham