This study is currently recruiting participants.
Number
17-EI-0112
Sponsoring Institute
National Eye Institute (NEI)
Recruitment Detail
Type: Participants currently recruited/enrolled 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)
Investigational Device(s)
Intervention(s)
Supporting Site
National Eye Institute
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.
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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 greater than or equal to 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 or worsening condition; 3. Participant has an oral intake of high doses of vitamin A palmitate supplement (greater than or equal to 10,000 international units (IU) per day); 4. Participant is an NEI employee or subordinate or co-worker of an investigator.
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 greater than or equal to 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 or worsening condition;
3. Participant has an oral intake of high doses of vitamin A palmitate supplement (greater than or equal to 10,000 international units (IU) per day);
4. Participant is an NEI employee or subordinate or co-worker of an investigator.
Principal Investigator
Referral Contact
For more information: