Study on Visual Function Impairments in Dry Age-related Macular Degeneration
Completed
Conditions studied: Age Related Macular Degeneration
In brief
The study hypothesis is that patients with dry age-related macular degeneration experience visual function impairments such as defects in dark adaptation, glare intolerance, poor light transition and reading in low lighting conditions. Studies have shown that patients in the early phases of AMD with normal visual acuity commonly reported difficulty with these visual functions but there have been no systematic studies evaluating these deficits in this population. This prospective, exploratory study will include up to 130 patients with dry AMD and 60 controls. These patients will undergo the following non-invasive visual function testing: * microperimetry with eye tracking * low luminance visual acuity * specialized color vision (cone-specific) * contrast testing and night vision testing. High-resolution spectral domain optical coherence tomography (SDOCT) images will be taken of the central retina using the Spectralis OCT unit. The values of visual function tested will be correlated with the findings on SDOCT (volume/amount of drusen present in early AMD). There are no known risks to the subjects beyond what is normal for standard examinations of the eye, visual function testing and standard ocular photographic procedures.
Key facts
- Study ID
- NCT01822873
- Run by
- Duke University
- People needed
- 128
- Starts
- 2013-03-01
- Expected to finish
- 2018-07-01
- Last updated by the study team
- 2019-04-17
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Capable and willing to provide consent
- Has been diagnosed with dry age-related macular degeneration stages 1-3
- At least 50 years of age
You may not qualify if…
- Unable or unwilling to give consent
- Under 50 years of age
- Presence of retinal pathology such as central geographic atrophy, hemorrhage or retinal fluid, and other macular pathology other than AMD
- Presence of dense cataracts in the study eye(s) that can affect visual function tests
- Presence of glaucoma requiring treatment during the study and/or visual field defects
- Presence retinal laser or surgical theraphy in study eye (s)
- Any of other ocular condition requiring long-term theraphy or surgery during the study
- Participant has photographically significant corneal or media opacities in either eye that would preclude adequate ophthalmic imaging and functional testing
- Diagnosis of nystagmus that will interfere with testing
- High myopia -8 Diopters or more severe
- Participant has, in the opinion of the Investigator, any physical or mental condition that would increase the risk of participation in the stduy or may interfere with the study procedures, evaluations and outcome assessments.
Where it is running
- Duke Eye Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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