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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 currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-EI-0112

Sponsoring Institute

National Eye Institute (NEI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 50
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

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.

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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 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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Catherine A. Cukras, M.D.
National Eye Institute (NEI)



Angel H. Garced, R.N.
National Eye Institute (NEI)
National Institutes of Health
Building 10
Room 10D45
10 Center Drive
Bethesda, Maryland 20892
(301) 594-3141
garceda@nei.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT03225131

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