Protocol Details
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)
This study is NOT currently recruiting participants.
Summary
Number | 17-EI-0112 |
Sponsoring Institute | National Eye Institute (NEI) |
Recruitment Detail | Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 50 Years
Max Age: 100 Years |
Referral Letter Required | Yes |
Population Exclusion(s) | Adults who are or may become unable to consent;
Children |
Keywords | Age Related Macular Degeneration;
Dark Adaptation;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Age-Related Macular Degeneration |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Eye Institute |
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.
Eligibility
INCLUSION CRITERIA:
Participants will be eligible if the following inclusion criteria are met:
1. Participant was enrolled in and completed 11-EI-0147. The minimum age of enrollment in 11-EI-0147 is 50;
2. Participant is able to understand and sign the protocol's informed consent document;
3. Participant is able to complete and comply with study assessments for the full duration of the study;
4. Participant has a BCVA score of >= 20/100 (Snellen equivalent) in study eye.
EXCLUSION CRITERIA:
Participants who meet any of the following criteria will be excluded from this study:
1. Participant has advanced AMD in the study eye at the baseline visit;
2. The participant has an intercurrent illness, adverse event (AE) or worsening condition;
3. Participant has an oral intake of high doses of vitamin A palmitate supplement (>= 10,000 international units (IU) per day);
4. Participant is an NEI employee or subordinate or co-worker of an investigator.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT03225131