Study of Dark Adaptation in Age-Related Macular Degeneration

Launched by NATIONAL EYE INSTITUTE (NEI) · May 11, 2011

Keywords

ClinConnect Summary

This clinical trial is studying a method to help identify and monitor early stages of age-related macular degeneration (AMD), a common cause of vision loss in people over 55. AMD affects central vision, which is crucial for seeing fine details. The researchers want to see if a test that measures how well the eyes adjust to darkness can help spot early signs of dry AMD before it becomes more serious.

To participate, you need to be at least 50 years old and either have early to middle dry AMD in one eye or have no AMD at all. The study lasts 5 years, and you would need to visit the research center at least nine times for eye exams and tests that check how your eyes respond to changing light conditions. Throughout the study, you'll also answer questions about your health and any medications you're taking. It's important to know that you will receive standard care for any eye conditions you might have during the trial.

Gender

ALL

Eligibility criteria

• * 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 greater than or equal to 50 years of age.
• • Participant has a BCVA score of greater than or equal to 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 (greater than or equal to 125 microns) in the study eye and no large drusen or advanced AMD in the fellow eye;
• • Group 2: Participant has bilateral large drusen (greater than or equal to 125 microns) with or without retinal pigment epithelial hypo/hyperpigmentary changes;
• • Group 3: Participant has at least one large drusen (greater than or equal to 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 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:
• • Participant has advanced AMD in the study eye at the baseline visit.
• • Participant has other active ocular or macular diseases (e.g., diabetic macular edema, retinal vein occlusion, Stargardt s disease or cone-rod dystrophy) or other known ocular disorders that have caused a visual field deficit (e.g., glaucoma with known visual field defect) in the study eye.
• • Participant has a fixation deficit in the study eye that would prevent the participant from performing the AdaptDxTM dark adaptation protocol.
• • Participant has a medical condition that the investigator feels would prevent the participant from complying with or being able to complete the study assessments
• • Participant had cataract surgery in the study eye within three months prior to enrollment.
• • 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).
• • Participant has or had hepatitis or liver disease. Abnormally low vitamin A can alter dark adaptation and chronic liver disease has been associated with low vitamin A.
• • Participant has a history of vitamin A deficiency.
• • Participant is an NEI employee or subordinate or co-worker of an investigator.