Study of Dark Adaptation in Age-Related Macular Degeneration (NCT01352975) | Clinical Trial Compass
CompletedNot Applicable
Study of Dark Adaptation in Age-Related Macular Degeneration
United States217 participantsStarted 2011-05-16
Plain-language summary
Background:
* Age-related macular degeneration (AMD) is a leading cause of vision loss in individuals over 55 years of age. It can cause permanent loss of central vision, which is important for seeing fine details and long distances. AMD has two forms: wet AMD and dry AMD. Most people with AMD have dry AMD. But dry AMD can progress to wet AMD. Wet AMD is the more serious form and can result in severe vision loss.
* A method to identify and monitor the early to middle stages of AMD may help researchers develop new treatments to stop the disease before it becomes severe. In early dry AMD, people cannot see well at night. Researchers want to study whether a procedure that measures how the eye adjusts to the dark can help to identify and monitor early to middle dry AMD.
Objectives:
\- To evaluate the effectiveness of using a dark adaptation protocol to identify and monitor early to middle dry age-related macular degeneration.
Eligibility:
\- People at least 50 years of age who have no AMD. Others who have early to middle dry AMD in at least one eye.
Design:
* People will be screened with a physical examination, medical history, blood and urine tests, and a full eye exam.
* This study will last 5 years and require at least 9 visits to NIH. (First visit; study visits at months 3, 6, 12, 18, and 24; and 3 yearly followup visits).
* Up to 10 people will be asked to come back to the clinic 1 week after their first visit. They will be asked to test the device to be used in the study.
* Participants will have baseline exams. These questions will be about problems that affect their eyes under different lighting conditions.
* At every visit, participants will answer questions about general health and current medications (including any vitamins or supplements). They will also have a full eye exam and a 20- to 40-minute test. This test measures how fast the eyes recover in response to decreasing levels of light. The test also measures how sensitive the eyes are to these conditions.
* Participants will continue to have these tests at the yearly followup examinations. They will be treated with the standard of care for any eye conditions they have or may develop during the study.
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:
Participants will be eligible if the following inclusion criteria are met:
* 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 is \>= 50 years of age.
* Participant has a BCVA score of \>= 20/100 (Snellen equivalent) in study eye.
* Participant qualifies for one of the following groups based on AMD grading as defined below.
* Group 0: Participant without AMD defined as no large drusen or advanced AMD in either eye;
* Group 1: Participant has at least one large drusen (\>= 125 microns) in the study eye and no large drusen or advanced AMD in the fellow eye;
* Group 2: Participant has bilateral large drusen (\>= 125 microns) with or without retinal pigment epithelial hypo/hyperpigmentary changes;
* Group 3: Participant has at least one large drusen (\>= 125 microns) in the study eye and advanced AMD in the fellow eye.
* Group 4: Participant has reticular pseudodrusen in the study eye defined as having (1) the presence of RPD on at least one en face imaging method (color photography, autofluorescence or infrared) and (2) confirmation of previously described findings of hyperreflective material located between the RPE and the photoreceptor ellipsoid zone on SD OCT in those areas.
EXCLUSION CRITERIA:
Participants who meet any of the following criteria will be excluded from this study:
* Partici…
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 how the eye adjusts to darkness over 12 and 24 months across different groups of AMD — which group would I fall into, and what does that mean for understanding how my condition might progress?
2Since this trial is completed and was measuring dark adaptation as a way to monitor AMD, has any published data from it shown whether dark adaptation testing could be a useful tool for tracking my own disease over time?
3This study was observational in nature rather than testing a treatment — does that mean it was gathering information to inform future therapies, and are there any follow-up treatment trials my doctor thinks I should know about based on what this research found?
4Dark adaptation measures how quickly my eyes adjust when going from light to dark — is this type of testing something my doctor currently uses or recommends to help monitor where I am in my AMD, and would it make sense for me to get a baseline measurement now?
5Given that this trial is now completed, would my doctor be able to use the findings from this research to give me a better sense of what my own dark adaptation changes might mean for my long-term vision outlook?
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 outcome is to determine mean change, including the distribution of change, in dark adaptation response between baseline and months 12 and 24 for Groups 0 - 4.