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NCT03225131 · ClinicalTrials.gov registry record
Dark Adaptation in Participants With Age-Related Macular Degeneration
A clinical trial of Age-related Macular Degeneration, sponsored by National Eye Institute (NEI).
- Active
- Registry status
- 57
- Enrollment target
- 1
- Study location
NCT03225131: Active study of Age-related Macular Degeneration, sponsored by National Eye Institute (NEI).
NCT03225131 is a study of Age-related Macular Degeneration that is active but no longer recruiting, run by National Eye Institute (NEI). The registered enrollment target is 57 participants, below the 1,507-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03225131, a study of Age-related Macular Degeneration, is active but no longer recruiting, sponsored by National Eye Institute (NEI).
- ACTIVE NOT RECRUITING
- Registry status
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Macular degeneration can cause permanent loss of central vision. This vision is important for seeing details. Age-related macular degeneration (AMD) is the leading cause of vision loss in people over 55 in the United States. Researchers want to follow people with AMD to study the early to middle stages of the disease. Objective: To follow for another 5 years participants who completed NIH study 11-EI-0147. Eligibility: Participant was enrolled in and completed study 11-EI-0147. Design: Participants will have at least 6 study visits over 5 years. Each visit takes about 5 hours. At visit 1, participants will be asked about their medical and eye disease history. They will have an eye exam. The exam will test vision, eye pressure, and eye movements. The pupil will be dilated with eye drops. Participants will have baseline exams. These include a health history and questions about problems that affect their eyes under different lighting. They will answer these questions each year. At each visit, participants will have some or all of these tests: Eye exam Dark adaptation protocol. This measures how fast the eyes recover when exposed to decreasing levels of light. The pupil will be dilated with eye drops. Participants will sit in front of a metal box with a camera inside. They will push a button when they see a light in the machine. View a bright background light for 5 minutes. After the light is turned off participants will push a button when a blue or red light is seen. Sit in the dark for about 30 minutes. Participants will push a button when they see a blue or red light.
Primary Outcome
The primary objective will be to determine mean change, including distribution of change in dark adaptation response between baseline and months 12, 24 and 48 in participants with varying degree of severity of AMD (Groups 0, 1, 2, 3 and 4).
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2017-06-16 |
| Est. Completion | 2033-12-31 |
What the registry record for NCT03225131 still lists
NCT03225131 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 1,507-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Age-related Macular Degeneration appearing as the primary indexed condition, and to 0 interventions.
NCT03225131 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03225131 about?
NCT03225131 is a clinical study titled "Dark Adaptation in Participants With Age-Related Macular Degeneration". Background: Macular degeneration can cause permanent loss of central vision. This vision is important for seeing details. Age-related macular degeneration (AMD) is the leading cause of vision loss in people over 55 in the United States. Researchers want to follow people with AMD to study the early ...
What is the current status of trial NCT03225131?
This trial is currently active not recruiting. The enrollment target is 57 participants. The study started on 2017-06-16. Estimated completion is 2033-12-31.
What conditions does trial NCT03225131 study?
This clinical trial studies the following conditions: Age-related Macular Degeneration.
Who is sponsoring clinical trial NCT03225131?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03225131 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03225131's enrollment target sits among peer trials
57 45th of 74 higher than 30 of 74 other Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Age-related Macular Degeneration trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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