Rod and Cone Mediated Function in Retinal Disease
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02617966|
Recruitment Status : Recruiting
First Posted : December 1, 2015
Last Update Posted : October 15, 2018
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.
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.
People ages 5 and older with:
Retinal disease OR
20/20 vision or better with or without correction in at least one eye
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 will have up to 6 more visits over 6-12 months. Visits include:
Eye exam and imaging
Time course of dark adaptation: Participants view a background light for 5 minutes then
push a button when they see colored light.
Dark adapted sensitivity: Participants sit in the dark for 45 minutes. They push a button when
they see colored light.
For participants with retinal disease, ERG and visual field testing
|Condition or disease|
|Retinal Degeneration Retinitis Pigmentosa Stargardt's Disease|
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 120 healthy volunteers and 250 participants, age five or older, with retinal disease.
Design: This single-center, observational, case-control study will be comprised of three related Aims that assess rod and cone function with the recently released commercial Medmont Dark Adapted Chromatic (DAC) perimeter and/or a commercial Cambridge Research Systems computer monitor (Display++) specialized for displaying stimuli at low light intensities. For Aim 1 the normal ranges will be established for dark-adapted retinal sensitivities to blue and red stimuli of the DAC perimeter, and for radial frequency (RF) hyperacuity on the Display++ monitor. 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, dark-adapted retinal sensitivity to the DAC blue and red stimuli, and/or RF hyperacuity on the Display++ monitor.
Outcome Measures: The primary outcome for this study is to establish normal ranges for A) the kinetics of dark adaptation (time), B) dark adapted retinal sensitivity (dB) for the Medmont DAC blue and red stimuli, and C) RF hyperacuity on the Display++ monitor. The secondary outcomes will be to examine changes in the kinetics of dark adaptation, dark adapted retinal sensitivity, and scotopic and photopic RF hyperacuity in participants with retinal disease.
|Study Type :||Observational|
|Estimated Enrollment :||370 participants|
|Official Title:||Rod and Cone Mediated Function in Retinal Disease|
|Study Start Date :||November 28, 2015|
|Estimated Primary Completion Date :||August 24, 2020|
|Estimated Study Completion Date :||August 24, 2020|
- The primary outcome for this study is to establish normal ranges for A) the kinetics of dark adaptation (time), B) dark adapted retinal sensitivity (dB) for the Medmont DAC blue and red stimuli, and C) RF hyperacuity on the Display++ monitor. [ Time Frame: Ongoing ]
- The secondary outcomes will be to examine changes in the kinetics of dark adaptation, dark adapted retinal sensitivity, and scotopic and photopic RF hyperacuity in participants with retinal disease. [ Time Frame: Ongoing ]
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): NCT02617966
|Contact: Daniel W Claus, R.N.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Brett G Jeffrey, Ph.D.||National Eye Institute (NEI)|