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Efficacy of Repeated Low-level Red-light Therapy in Myopia Control

Primary Purpose

Myopia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-level Red Light Therapy Device
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring myopia

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Provision of consent Age: ≥8 and ≤13 years at enrollment Myopia: Spherical equivalent refractions (SERs) under cycloplegia: -1.00 to -5.00 diopters (D) Astigmatism of 2.50 D or less Anisometropia of 1.50 D or less Corrected monocular logMAR visual acuity (VA): 1.0 or better Consent to participate in random allocation of grouping Fluent in English Willing and able to participate in all required activities of the study Race/ethnicity is either African, Hispanic, or Caucasian. Exclusion Criteria: Strabismus and binocular vision abnormalities in either eye Ocular abnormalities in either eye or other systemic abnormalities that affect participate in all required activities of the study. Prior treatment of myopia control in either eye, including but not limited to drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc. Other reasons, including but not limited to severe physical and cognitive disability, that the physician may consider inappropriate for enrollment Noncompliance with treatment Children whose parents do not sign informed consent

Sites / Locations

  • University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Low Level Red Light Treatment Arm

Control Treatment Arm

Arm Description

On top of wearing single vision spectacles, subjects in the intervention group will receive low-level red light treatment twice a day from Monday to Friday, with each treatment lasting for 3 minutes at a minimal interval of 4 hours.

Subjects in the control group will wear single vision spectacles.

Outcomes

Primary Outcome Measures

Axial Length (AL) (mm) at Baseline
Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.
Axial Length (AL) (mm) at Month 1
Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.
Axial Length (AL) (mm) at Month 3
Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.
Axial Length (AL) (mm) at Month 6
Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.
Axial Length (AL) (mm) at Year 1
Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2022
Last Updated
October 16, 2023
Sponsor
University of California, San Francisco
Collaborators
University of Melbourne
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1. Study Identification

Unique Protocol Identification Number
NCT05606237
Brief Title
Efficacy of Repeated Low-level Red-light Therapy in Myopia Control
Official Title
Efficacy of Repeated Low-level Red-light Therapy in Myopia Control: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
July 14, 2025 (Anticipated)
Study Completion Date
July 14, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of Melbourne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Low-level red-light technology provides a new and innovative myopia control approach. This strategy enables relatively high energies of light to be delivered at much shorter durations of exposure to induce the myopia control effect. The efficacy of the low-level red-light technology has been proven in a Chinese population. This trial demonstrated that 3-minutes per session twice a day repeated low-level red-light treatment controlled 87.7% of refraction progression and 76.8% of axial length elongation when the time of compliance to the treatment was 75%. Repeating this RCT in culturally diverse groups will confirm and translate this technology into a solution for myopia control globally.
Detailed Description
The purpose of this study is to assess the safety and efficacy of low level red light therapy in myopia control in African, Hispanic, and Caucasian children. This is a prospective, multi-ethnic, parallel-controlled randomized trial that will enroll myopic children aged 8-13 years old as subjects. On top of wearing single vision spectacles, subjects in the intervention group will receive treatment twice a day from Monday to Friday, with each treatment lasting for 3 minutes at a minimal interval of 4 hours. Subjects in the control group will wear single vision spectacles. The study will evaluate axial elongation, cycloplegic spherical equivalent change, changes in other biological parameters (except axial length), and uncorrected and best corrected visual acuity of the two groups of subjects at 1 month, 3 months, 6 months, and 12 months after enrollment. The study plans to conduct an interim analysis at a three-month follow-up. The enrollment target is 90 participants: 30 Hispanic Children (15 control and 15 treatment) , 30 African Children (15 control and 15 treatment), and 30 Caucasian Children (15 control and 15 treatment).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This trial is a single-center, multi-ethnic, single-blind, parallel-group randomized controlled trial designed to evaluate the efficacy and safety of low level red light treatment on myopia among multi-ethnic schoolchildren.
Masking
Care Provider
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Level Red Light Treatment Arm
Arm Type
Experimental
Arm Description
On top of wearing single vision spectacles, subjects in the intervention group will receive low-level red light treatment twice a day from Monday to Friday, with each treatment lasting for 3 minutes at a minimal interval of 4 hours.
Arm Title
Control Treatment Arm
Arm Type
No Intervention
Arm Description
Subjects in the control group will wear single vision spectacles.
Intervention Type
Device
Intervention Name(s)
Low-level Red Light Therapy Device
Intervention Description
The treatment device used in this study is a semi-conductor laser product (Eyerising International Pty Ltd, Melbourne, Australia), emitting low-level red-light with a wavelength of 650 ± 10 nm. Based on calculations done by the manufacturer, the device provides light at a power of 2.00 ± 0.50 mW.
Primary Outcome Measure Information:
Title
Axial Length (AL) (mm) at Baseline
Description
Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.
Time Frame
1 month
Title
Axial Length (AL) (mm) at Month 1
Description
Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.
Time Frame
1 month
Title
Axial Length (AL) (mm) at Month 3
Description
Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.
Time Frame
3 months
Title
Axial Length (AL) (mm) at Month 6
Description
Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.
Time Frame
6 months
Title
Axial Length (AL) (mm) at Year 1
Description
Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provision of consent Age: ≥8 and ≤13 years at enrollment Myopia: Spherical equivalent refractions (SERs) under cycloplegia: -1.00 to -5.00 diopters (D) Astigmatism of 2.50 D or less Anisometropia of 1.50 D or less Corrected monocular logMAR visual acuity (VA): 1.0 or better Consent to participate in random allocation of grouping Fluent in English Willing and able to participate in all required activities of the study Race/ethnicity is either African, Hispanic, or Caucasian. Exclusion Criteria: Strabismus and binocular vision abnormalities in either eye Ocular abnormalities in either eye or other systemic abnormalities that affect participate in all required activities of the study. Prior treatment of myopia control in either eye, including but not limited to drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc. Other reasons, including but not limited to severe physical and cognitive disability, that the physician may consider inappropriate for enrollment Noncompliance with treatment Children whose parents do not sign informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julius Oatts, MD
Phone
(415) 353-2800
Email
julius.oatts@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julius Oatts, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashika Kuchhangi
Phone
510-646-2065
Email
ashika.Kuchhangi@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Julius Oatts, MD
First Name & Middle Initial & Last Name & Degree
Ying Han, MD/PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results after deidentification(text, tables, figures, and appendices).
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. For individual participant data meta-analysis.
Citations:
PubMed Identifier
26875007
Citation
Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.
Results Reference
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Efficacy of Repeated Low-level Red-light Therapy in Myopia Control

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