Status:
COMPLETED
Functionally Validated Structural Endpoints for Early AMD
Lead Sponsor:
Cynthia Owsley
Collaborating Sponsors:
National Eye Institute (NEI)
National Institutes of Health (NIH)
Conditions:
Age-related Macular Degeneration
Aging
Eligibility:
All Genders
20+ years
Brief Summary
Delayed rod-mediated dark adaptation (RMDA), or delayed recovery of vision in a dark environment, is a functional biomarker (i.e., risk factor) for early age-related macular degeneration (AMD). This r...
Detailed Description
The Alabama Study on Early Age-Related Macular Degeneration 2 (ALSTAR2) is a prospective cohort study with baseline measurements that are repeated at follow-up 3 years later. The baseline and 3 year f...
Eligibility Criteria
Inclusion
- For those in Normal Macular Health or Early AMD: aged ≥ 60 years; either have normal macular health in both eyes at baseline or have early AMD in one eye For Young Normals: aged 20-30 years old; normal macular health in both eyes.
Exclusion
- Exclusion for those in normal macular health are:
- ANY EYE CONDITION OR DISEASE IN EITHER EITHER (OTHER THAN EARLY CATARACT) THAT CAN IMPAIR VISION INCLUDING:
- diabetic retinopathy
- glaucoma
- ocular hypertension
- history of retinal diseases (e.g., retinal vein occlusion, retinal degenerations)
- optic neuritis
- corneal disease
- previous ocular trauma or surgery
- REFRACTIVE ERROR \>- 6 DIOPTERS
- NEUROLOGICAL CONDITIONS THAT CAN IMPAIR VISION OR JUDGEMENT INCLUDING:
- multiple sclerosis
- Parkinson disease
- stroke
- Alzheimer disease
- seizure disorders
- brain tumor
- traumatic brain injury
- PSYCHIATRIC DISORDERS THAT COULD IMPAIR THE ABILITY:
- to follow simple directions
- answer questions about health and functioning
- or to provide informed consent
- DIABETES
- ANY MEDICAL CONDITION THAT CAUSES SIGNIFICANT FRALITY OR IS BELIEVED TO BE TERMINAL.
- Exclusion criteria for the early AMD group:
- These are identical to those described above, except that it is acceptable for participants to have early AMD (AREDS 2-4) in one eye and be AREDS grade 1 or any stage of AMD in the fellow eye.
- Exclusion for Young Normals:
- ANY EYE CONDITION OR DISEASE IN EITHER EYE (OTHER THAN EARLY CATARACT) THAT CAN IMPAIR VISION INCLUDING:
- diabetic retinopathy
- glaucoma
- ocular hypertension
- history of retinal diseases (e.g., retinal vein occlusion, retinal degenerations)
- optic neuritis, corneal disease
- previous ocular trauma or surgery
- RERACTIVE ERROR \>=6 DIOPTORS
- NEUROLOGICAL CONDITIONS THAT CAN IMPAIR VISION OR JUDGEMENT INCLUDING:
- multiple sclerosis
- Parkinson disease
- stroke
- Alzheimer disease
- seizure disorders
- brain tumor
- traumatic brain injury
- PSYCHIATRIC DISORDERS THAT COULD IMPAIR THE ABILITY TO:
- follow simple directions
- answer questions about health and functioning
- or to provide informed consent
- DIABETES
- ANY MEDICAL CONDITION THAT CAUSES SIGNIFICANT FRAILTY OR IS BELIEVED TO BE TERMINAL.
Key Trial Info
Start Date :
October 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
556 Patients enrolled
Trial Details
Trial ID
NCT04112667
Start Date
October 7 2019
End Date
October 31 2024
Last Update
September 26 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294