NCT05852782

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2020

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
Last Updated

May 10, 2023

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

April 27, 2023

Last Update Submit

May 7, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Choroidal Thickness

    The choroid will be imaged with OCT to determine choroidal thickness

    one hour

  • Pupil response

    The pupil response will be measured before and after one hour to see if exposure to light affects the diameter

    one hour

Study Arms (4)

Light exposure broadband

EXPERIMENTAL

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

Other: White Light therapy

Light exposure long wavelength

EXPERIMENTAL

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

Other: Red light therapy

Light exposure short wavelength

EXPERIMENTAL

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

Other: Blue light therapy

Light exposure darkness

EXPERIMENTAL

Participants will be exposed to darkness for one hour

Other: Darkness

Interventions

Participants will be exposed to broadband light for one hour

Light exposure broadband

Participants will be exposed to blue light for one hour

Light exposure short wavelength

Participants will be exposed to re light for one hour

Light exposure long wavelength

Participants will be in complete darkness for one hour

Light exposure darkness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston College of Optometry

Houston, Texas, 77004, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Myopia

Interventions

PhototherapyDarkness

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsLightOptical PhenomenaPhysical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: All subjects will participate in four conditions on separate days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 10, 2023

Study Start

February 1, 2019

Primary Completion

December 31, 2019

Study Completion

February 2, 2020

Last Updated

May 10, 2023

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations