NCT04073238

Brief Summary

The purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in Chinese schoolchildren.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

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

July 23, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 29, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 6, 2022

Status Verified

January 1, 2022

Enrollment Period

3.4 years

First QC Date

August 18, 2019

Last Update Submit

January 5, 2022

Conditions

MyopiaRefractive ErrorsEye Diseases

Outcome Measures

Primary Outcomes (1)

  • Axial length change (mm)

    Axial length change (mm) is characterized as the difference between each follow-up visit and baseline values. The IOLMaster is used to measure axial length (mm).

    1 month, 3 months, 6 months and 1 year

Secondary Outcomes (9)

  • Cycloplegic spherical equivalent change (Diopter)

    1 month, 3 months, 6 months and 1 year

  • Corneal curvature change (mm)

    1 month, 3 months, 6 months and 1 year

  • Anterior chamber depth change (mm)

    1 month, 3 months, 6 months and 1 year

  • White to white change (mm)

    1 month, 3 months, 6 months and 1 year

  • Visual acuity change

    1 month, 3 months, 6 months and 1 year

  • +4 more secondary outcomes

Other Outcomes (5)

  • Axial length change (mm)

    2 years

  • Cycloplegic spherical equivalent change (Diopter)

    2 years

  • Visual acuity change

    2 years

  • +2 more other outcomes

Study Arms (2)

Single vision spectacle lens

NO INTERVENTION

Single vision lens with power for correcting distance refraction.

Repeated low-level red-light therapy

EXPERIMENTAL

Single vision lens \& repeated low-level red-light therapy

Device: Low-level Red-light Therapy

Interventions

Low-level Red-light TherapyDEVICE

In addition to wearing single vision spectacle lens with power for correcting distance refraction, low-level red-light therapy is performed twice per school day at home with an interval of at least 4 hours, each treatment lasting 3 minutes.

Repeated low-level red-light therapy

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age at enrolment: 8-13 years
  • Spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D)
  • Astigmatism of 2.50 D or less
  • Anisometropia of 1.5 D or less
  • Spectacle corrected monocular logMAR visual acuity (VA): 0 or better
  • Parents' understanding and acceptance of random allocation of grouping

You may not qualify if:

  • Strabismus and binocular vision abnormalities in either eye
  • Ocular abnormalities in either eye or other systemic abnormalities
  • Prior treatment of myopia control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye
  • Other contraindications in either eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The Second People's Hospital of Foshan

Foshan, Guangdong, 528000, China

Location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Shenzhen Children's Hospital

Shenzhen, Guangdong, 518038, China

Location

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

Location

Related Publications (2)

  • Wang W, Jiang Y, Zhu Z, Zhang S, Xuan M, Tan X, Kong X, Zhong H, Bulloch G, Xiong R, Yuan Y, Chen Y, Zhang J, Zeng J, Morgan IG, He M. Axial Shortening in Myopic Children after Repeated Low-Level Red-Light Therapy: Post Hoc Analysis of a Randomized Trial. Ophthalmol Ther. 2023 Apr;12(2):1223-1237. doi: 10.1007/s40123-023-00671-7. Epub 2023 Feb 15.

    PMID: 36790672DERIVED

  • Xiong R, Zhu Z, Jiang Y, Wang W, Zhang J, Chen Y, Bulloch G, Yuan Y, Zhang S, Xuan M, Zeng J, He M. Longitudinal Changes and Predictive Value of Choroidal Thickness for Myopia Control after Repeated Low-Level Red-Light Therapy. Ophthalmology. 2023 Mar;130(3):286-296. doi: 10.1016/j.ophtha.2022.10.002. Epub 2022 Oct 11.

    PMID: 36240954DERIVED

MeSH Terms

Conditions

MyopiaRefractive ErrorsEye Diseases

Study Officials

  • Mingguang He, Professor

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2019

First Posted

August 29, 2019

Study Start

July 23, 2019

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 6, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Locations

CN(4)