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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05852782
Other study ID # STUDY00001524
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date February 2, 2020

Study information

Verified date January 2019
Source University of Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 2, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
White Light therapy
Participants will be exposed to broadband light for one hour
Blue light therapy
Participants will be exposed to blue light for one hour
Red light therapy
Participants will be exposed to re light for one hour
Darkness
Participants will be in complete darkness for one hour

Locations

Country Name City State
United States University of Houston College of Optometry Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Houston

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Choroidal Thickness The choroid will be imaged with OCT to determine choroidal thickness one hour
Primary Pupil response The pupil response will be measured before and after one hour to see if exposure to light affects the diameter one hour
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