Clinical Trial: Rod and Cone Mediated Function in Retinal Disease
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Rod and Cone Mediated Function in Retinal Disease
Brief Summary:
Background:
Retinal diseases cause the loss of rod and cone photoreceptors. Symptoms include vision loss and night blindness. Researchers want to learn about rod and cone function in healthy people and people with retinal disease. They want to know if how well a person sees in the dark can test the severity of retinal disease.
Objectives:
To find out if how well a person sees in the dark can test the severity of retinal disease. To find out if this can help detect retinal disease and track its changes.
Eligibility:
People ages 5 and older with:
Retinal disease OR
20/20 vision or better with or without correction in at least one eye
Design:
Participants will be screened with medical and eye history and eye exam. Those with retinal disease will also have:
Eye imaging: Drops dilate the eye and pictures are taken of it.
Visual field testing: Participants look into a bowl and press a button when they see light.
Electroretinogram (ERG): An electrode is taped to the forehead. Participants sit in the
dark with their eyes patched for 30 minutes. Then they get numbing drops and contact
lenses. Participants watch lights while retina signals are recorded.
Visit 1 will be 3 8 hours. Participants wi
Detailed Summary:
Objective:
The objective of this protocol is to investigate local changes in rod and cone photoreceptor function across the retina in healthy volunteers and participants with retinal disease.
Study Population:
Up to 80 healthy volunteers and 250 participants, age 5 or older, with retinal disease.
Design:
This single-center, observational, case-control study will be comprised of three related aims that all make use of a recently released commercial Dark Adapted Chromatic (DAC) perimeter. For aim 1 the normal ranges will be established for dark-adapted retinal sensitivities to blue and red stimuli of the DAC perimeter. For aim 2, the normal range will be established for describing the kinetics of dark adaptation following bleaching of retinal rhodopsin for the DAC perimeter. For aim 3, local changes in rod and cone photoreceptor function across the retina in participants with retinal disease will be examined from measurement of the kinetics of dark adaptation and/or dark-adapted retinal sensitivity to the DAC blue and red stimuli.
Outcome Measures:
The primary outcome for this study is to establish normal ranges for the kinetics of dark adaptation (time) and dark adapted retinal sensitivity (dB) for the Medmont DAC blue and red stimuli. The secondary outcomes will be to examine changes in the kinetics of dark adaptation and dark adapted retinal sensitivity in participants with retinal disease.
Sponsor: National Eye Institute (NEI)
Current Primary Outcome: The primary outcome for this study is to establish normal ranges for the kinetics of dark adaptation (time) and dark adapted retinal sensitivity (dB) for the Medmont DAC blue and red stimuli. [ Time Frame: Ongoing ]
Original Primary Outcome: Same as current
Current Secondary Outcome: The secondary outcomes will be to examine changes in the kinetics of dark adaptation and dark adapted retinal sensitivity in participants with retinal disease. [ Time Frame: Ongoing ]
Original Secondary Outcome: Same as current
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: November 28, 2015
Date Started: November 20, 2015
Date Completion: August 24, 2020
Last Updated: April 21, 2017
Last Verified: March 29, 2017
