Study on Visual Function Impairments in Dry Age-related Macular Degeneration
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01822873|
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : April 17, 2019
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.
|Condition or disease|
|Age Related Macular Degeneration|
|Study Type :||Observational|
|Actual Enrollment :||128 participants|
|Official Title:||Evaluation of Visual Function Impairments in Patients With Early Dry Age-related Macular Degeneration|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||July 2018|
|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 ]
- Change in cone specific contrast sensitivity [ Time Frame: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months ]
- Change in contrast sensitivity [ Time Frame: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months ]
- Change in macular sensitivity on microperimetry [ Time Frame: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822873
|United States, North Carolina|
|Duke Eye Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Eleonora Lad, MD, PhD||Duke University|