NCT03225131Completed
Dark Adaptation in Participants With Age-Related Macular Degeneration
A Long-term Follow-up Study of Participants Enrolled in 11-EI-0147: Longitudinal Investigation of Dark Adaptation in Participants With Age-Related Macular Degeneration (DA_AMD)
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 57 (actual)
- First submitted
- 20 Jul 2017
- Start date
- 16 Jun 2017
- Primary completion date
- 15 Aug 2025
- Lead sponsor
- National Eye Institute (NEI)
- Diseases
- Macular degeneration
- NCT number
- NCT03225131
What you commit to
- Study type: Observational
- Participants enrolled: 57
- From 16 Jun 2017 to the primary completion date, 15 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- The participant has an intercurrent illness, adverse event (AE) or worsening condition;
Other
- Participants who meet any of the following criteria will be excluded from this study:
- Participant has advanced AMD in the study eye at the baseline visit;
- Participant has an oral intake of high doses of vitamin A palmitate supplement (\>= 10,000 international units (IU) per day);
- Participant is an NEI employee or subordinate or co-worker of an investigator.
Criteria the registry did not label
- INCLUSION CRITERIA:
- Participants will be eligible if the following inclusion criteria are met:
- Participant was enrolled in and completed 11-EI-0147. The minimum age of enrollment in 11-EI-0147 is 50;
- Participant is able to understand and sign the protocol's informed consent document;
- Participant is able to complete and comply with study assessments for the full duration of the study;
- Participant has a BCVA score of \>= 20/100 (Snellen equivalent) in study eye.
Age in the registry: 50 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.