NCT05786586

Brief Summary

A multicenter randomized controlled trial, evaluating the efficacy and safety of 650nm low-level red-light irradiation for myopia control and prevention in children. Participants included children(aged 6 to 12 years, spherical equivalent error of 0.5D or below) who are already myopic at recruitment, and those who are of Emmetropia or low hyperopia.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
572

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress84%
Mar 2023Dec 2026

First Submitted

Initial submission to the registry

January 29, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 26, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

3.8 years

First QC Date

January 29, 2023

Last Update Submit

September 23, 2024

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

  • Change in axial length

    Use an optical biometer to measure the axial length.

    Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up

  • Change in spherical equivalent error

    Children's pupil were dilated using Mydrin-P eye drops, and then the refractive error was measured using an autorefractor. the two measurements (axial length and spherical equivalent error) will be aggregated to arrive at one reported value through the following way: axial enlongation will be defined as progress in myopia, decrease in spherical equivalent error will be defined as progress in myopia too.

    Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up

Secondary Outcomes (6)

  • Change in Choroid thickness

    Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up

  • Change in steep keratometry

    Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up

  • Change in flat keratometry

    Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up

  • Change in length thickness

    Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up

  • Change in anterior chamber depth

    Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up

  • +1 more secondary outcomes

Other Outcomes (1)

  • Fundus injury related to 650 nm low-level red-light irridiation

    Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up

Study Arms (2)

650 nm low-level red-light, plus single vision spectacle lenses

EXPERIMENTAL

Children in the treatment group are expected to receive 6 minutes irradiation of 650 nm low-level red-light daily, divided into two times a day, each lasting for 3 minutes. Single vision spectacle lenses are allowed for myopic children.

Device: 650 nm low-level red-light

Control

NO INTERVENTION

Single vision spectacle lenses are allowed for myopic children. No intervention was given.

Interventions

650 nm low-level red-lightDEVICE

650 nm low-level red-light is a kind of laser, concentrated into a beam, to repeatedly irradiate the retina

650 nm low-level red-light, plus single vision spectacle lenses

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6 to 12 years
  • The cycloplegic spherical equivalent error (SER) is -6D to 1D (\> -6D, ≤1D) in both eyes
  • Astigmatism of 2.5 D or less (≤2.5D)
  • Willing to participate in the study and sign the informed consent form

You may not qualify if:

  • Using other myopia interventions or stopped using them for less than three months, including but not limited to atropine eye drops or orthokeratology lens
  • With anisometropia (difference in sphere between two eyes was 1.5D or greater), strabismus, or amblyopia
  • With refractive media opacification (keratopathy, lens opacity, etc.)
  • Allergy to cycloplegia drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100005, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Ying Jie

    Beijing Tongren Hospital

    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
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

January 29, 2023

First Posted

March 27, 2023

Study Start

March 26, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)