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NCT03166202 · ClinicalTrials.gov registry record
Age-Related Macular Degeneration, Scotopic Dysfunction, and Driving Performance in a Simulator
A clinical trial, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- 40
- Enrollment target
NCT03166202: Completed study, sponsored by University of Alabama at Birmingham.
NCT03166202 is a clinical trial that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03166202 has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- 40 participants
- Enrollment target
Study Summary
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.
Primary Outcome
rate of rod-mediated dark adaptation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-09-01 |
| Est. Completion | 2019-03-05 |
What the finished NCT03166202 record still lists
NCT03166202 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03166202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03166202 about?
NCT03166202 is a clinical study titled "Age-Related Macular Degeneration, Scotopic Dysfunction, and Driving Performance in a Simulator". 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 reg...
What is the current status of trial NCT03166202?
This trial is currently completed. The enrollment target is 40 participants. The study started on 2018-09-01. Estimated completion is 2019-03-05.
Who is sponsoring clinical trial NCT03166202?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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