- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05852782
Effects of Light on the Choroid and Pupil
Effects of Narrowband and Broadband Light on Choroidal Thickness and Melanopsin-driven Pupil Response
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ambient light exposure is associated with choroid thickness and eye growth. The spectral composition of light, which has been shown to play a role in eye growth, can differentially regulate changes in choroid thickness by forming a focal point either in front of the retina in the case of short wavelength blue light or behind the retina in the case of long wavelength red light. In addition, melatonin suppression and the pupil light response, specifically, that driven by the intrinsically photosensitive retinal ganglion cells (ipRGCs), are most sensitive to short wavelength blue light. Therefore, the role of the wavelength of light on eye growth may involve ipRGC activity. As such, it is relevant to determine whether exposure to monochromatic light will alter choroidal thickness, ipRGC activity and melatonin levels.
The purpose of this study is to compare the short-term changes in choroid thickness, melatonin concentration, and the ipRGC-driven pupillary light response following one hour of light therapy with either short wavelength blue light or long wavelength red light. It has previously been shown that a one week period of daily morning light therapy produces a short term increase in choroid thickness throughout the day. Therefore, the investigators hypothesize that one hour of morning light therapy with short wavelength blue light will result in different effects in the changes in choroid thickness, melatonin levels, and the ipRGC-driven pupillary light response compared to one hour of morning light therapy with long wavelength red light.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77004
- University of Houston College of Optometry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ages 18-64
- must be able to comply with the experimental protocol, including collecting saliva and being present for the experiment in the lab on four separate occasions.
- must be willing to abstain from the use of sleep aids 12 hours prior to and for the duration of the study.
- must also be willing to abstain from alcohol and caffeinated beverages (coffee, espresso, energy drinks) or foods enriched with caffeine, such as power bars, the morning of and during each of the four experimental sessions.
Exclusion Criteria:
- age < 18 or >64 years old
- not willing to collect a saliva sample or be present in the lab on four separate occasions.
- ocular disease that may affect retinal light levels and function (e.g. glaucoma, significant cataract, etc.)
- use of prescription or over-the-counter medications known to affect sleep and cortisol levels.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Light exposure broadband
Participants will be exposed to indoor levels of light that appear colorless for one hour
|
Participants will be exposed to broadband light for one hour
|
Experimental: Light exposure long wavelength
Participants will be exposed to indoor levels of light that appear red for one hour
|
Participants will be exposed to re light for one hour
|
Experimental: Light exposure short wavelength
Participants will be exposed to indoor levels of light that appear blue for one hour
|
Participants will be exposed to blue light for one hour
|
Experimental: Light exposure darkness
Participants will be exposed to darkness for one hour
|
Participants will be in complete darkness for one hour
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Choroidal Thickness
Time Frame: one hour
|
The choroid will be imaged with OCT to determine choroidal thickness
|
one hour
|
Pupil response
Time Frame: one hour
|
The pupil response will be measured before and after one hour to see if exposure to light affects the diameter
|
one hour
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001524
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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