Study on Visual Function Impairments in Dry Age-related Macular Degeneration
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.
Age Related Macular Degeneration
|Study Design:||Time Perspective: Prospective|
|Official Title:||Evaluation of Visual Function Impairments in Patients With Early Dry Age-related Macular Degeneration|
- Change in low luminance visual acuity [ Time Frame: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
- Change in cone specific contrast sensitivity [ Time Frame: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
- Change in contrast sensitivity [ Time Frame: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
- Change in macular sensitivity on microperimetry [ Time Frame: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2013|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
|Age-related macular degeneration|
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01822873
|United States, North Carolina|
|Duke Eye Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Eleonora Lad, MD, PhD||Duke University|