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Effects of Light on the Choroid and Pupil

Primary Purpose

Emmetropia, Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
White Light therapy
Blue light therapy
Red light therapy
Darkness
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Emmetropia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Houston College of Optometry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Light exposure broadband

Light exposure long wavelength

Light exposure short wavelength

Light exposure darkness

Arm Description

Participants will be exposed to indoor levels of light that appear colorless for one hour

Participants will be exposed to indoor levels of light that appear red for one hour

Participants will be exposed to indoor levels of light that appear blue for one hour

Participants will be exposed to darkness for one hour

Outcomes

Primary Outcome Measures

Choroidal Thickness
The choroid will be imaged with OCT to determine choroidal thickness
Pupil response
The pupil response will be measured before and after one hour to see if exposure to light affects the diameter

Secondary Outcome Measures

Full Information

First Posted
April 27, 2023
Last Updated
May 7, 2023
Sponsor
University of Houston
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1. Study Identification

Unique Protocol Identification Number
NCT05852782
Brief Title
Effects of Light on the Choroid and Pupil
Official Title
Effects of Narrowband and Broadband Light on Choroidal Thickness and Melanopsin-driven Pupil Response
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
February 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Monochromatic light creates longitudinal chromatic aberration, with short wavelength blue light forming a focal point in front of the retina and long wavelength red light forming a focal point behind the retina. The investigators hypothesize that such chromatic aberrations, induced by exposure to red or blue LED lights, will cause the choroid behind the retina to respond to bring the image into focus by modulating its thickness, either thickening in the case of blue light or thinning in the case of red light. The magnitude and direction of this response is difficult to predict as previous studies have shown opposite findings in non-human primates and rodents. Furthermore, the investigators hypothesize that exposure to red or blue light will induce changes in how the pupil responds to light, because the cells in the eye that are involved in pupil control are most sensitive to blue light.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emmetropia, Myopia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All subjects will participate in four conditions on separate days
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Light exposure broadband
Arm Type
Experimental
Arm Description
Participants will be exposed to indoor levels of light that appear colorless for one hour
Arm Title
Light exposure long wavelength
Arm Type
Experimental
Arm Description
Participants will be exposed to indoor levels of light that appear red for one hour
Arm Title
Light exposure short wavelength
Arm Type
Experimental
Arm Description
Participants will be exposed to indoor levels of light that appear blue for one hour
Arm Title
Light exposure darkness
Arm Type
Experimental
Arm Description
Participants will be exposed to darkness for one hour
Intervention Type
Other
Intervention Name(s)
White Light therapy
Intervention Description
Participants will be exposed to broadband light for one hour
Intervention Type
Other
Intervention Name(s)
Blue light therapy
Intervention Description
Participants will be exposed to blue light for one hour
Intervention Type
Other
Intervention Name(s)
Red light therapy
Intervention Description
Participants will be exposed to re light for one hour
Intervention Type
Other
Intervention Name(s)
Darkness
Intervention Description
Participants will be in complete darkness for one hour
Primary Outcome Measure Information:
Title
Choroidal Thickness
Description
The choroid will be imaged with OCT to determine choroidal thickness
Time Frame
one hour
Title
Pupil response
Description
The pupil response will be measured before and after one hour to see if exposure to light affects the diameter
Time Frame
one hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Houston College of Optometry
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32832970
Citation
Lou L, Ostrin LA. Effects of Narrowband Light on Choroidal Thickness and the Pupil. Invest Ophthalmol Vis Sci. 2020 Aug 3;61(10):40. doi: 10.1167/iovs.61.10.40.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/32832970/
Description
published manuscript

Learn more about this trial

Effects of Light on the Choroid and Pupil

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