Dark Adaptation in Participants With Age-Related Macular Degeneration (NCT03225131) | Clinical Trial Compass
CompletedNot Applicable
Dark Adaptation in Participants With Age-Related Macular Degeneration
United States57 participantsStarted 2017-06-16
Plain-language 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.
Who can participate
Age range
50 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Participant has advanced AMD in the study eye at the baseline visit;
. The participant has an intercurrent illness, adverse event (AE) or worsening condition;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study tracked dark adaptation — the eye's ability to adjust from bright to dim light — over up to 4 years in people with AMD; can you explain what my own dark adaptation results look like and whether that kind of testing is something we should be doing to monitor my condition?
2Since this trial has already been completed, have its findings about how dark adaptation changes across different stages of AMD been published, and could they tell us anything useful about where my AMD currently sits on that spectrum?
3The study followed people with varying degrees of AMD severity — does my specific stage of AMD match the type of patients who were enrolled, and would dark adaptation testing be a meaningful measure for someone at my stage?
4Given that this was an observational study measuring changes over time rather than testing a treatment, what does this kind of research actually add to how doctors like you make decisions about monitoring or treating AMD?
5Are there current clinical trials or standard-of-care options that build on what studies like this one have found about dark adaptation as an early or prognostic marker for AMD progression that might be worth exploring for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.