NCT05811598

Brief Summary

Repeated Red Light Therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. However, ultra low lever of red light therapy with irradiance of 0.37mW and 0.60mW effectiveness and safety for 3\~ 6 year-old myopia treatment or slow myopia progression are seldom reported.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

March 21, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

March 31, 2023

Last Update Submit

April 22, 2023

Conditions

MyopiaAmblyopia

Keywords

MyopiaChildrenLLLTPBM

Outcome Measures

Primary Outcomes (1)

  • Mean changes of axial length vaules by millimeter at follow-up from baseline.

    Ocular axial length measured by IOLmaster500 or Lenstar will be measured and recorded at follow-ups and at baseline. The changes values of axial length of both groups will be compared as the main outcome to compare the effectiveness of repeated red light thearpy.

    at 3-month and at 6-month

Secondary Outcomes (2)

  • Numbers of children without myopic refraction changes by spherical equivalence values from refraction at follow-up from baseline(D)

    at 3-month and at 6-month

  • Number of Participants with unsafety issues during the study

    at 6-month

Other Outcomes (1)

  • Rate of subjects meet with repeated red light thearpy greater than 85% of the specified requirementsfrequence record

    at 1-month, 3-month and 6-month

Study Arms (2)

repeated red light therapy for 3~4 year-old myopia

EXPERIMENTAL

0.37mW lighting with wavelength of 650nm for the age of 3\~4 years old(including both 3 and 4 years)myopia.

Device: repeated ultra low lever red light

repeated red light therapy for 5~6 year-old myopia

EXPERIMENTAL

0.60mW lighting with wavelength of 650nm for the age of 5\~6 years old(including both 5 and 6 years)myopia.

Device: repeated ultra low lever red light

Interventions

repeated ultra low lever red lightDEVICE

Myopia indoor lighting therapy

Also known as: LLLT, PBM therapy
repeated red light therapy for 3~4 year-old myopiarepeated red light therapy for 5~6 year-old myopia

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \~6 years old;
  • Myopia Spherical Equivalence Refraction \<=-0.50D;
  • Written Informed Consent;

You may not qualify if:

  • Cannot approval with written informed consent;
  • Photophobia or allergy to red light;
  • With other severe conditions the principle investigators refused to enroll this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510600, China

RECRUITING

MeSH Terms

Conditions

MyopiaAmblyopia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Chao He, PhD

    Beijing Airdoc Technology Co., Ltd.

    STUDY DIRECTOR

  • Daoman Xiang, MD, PhD

    Guangzhou Women and Children's Medical Center

    PRINCIPAL INVESTIGATOR

  • Wensi Shen, MD, PhD

    Guangzhou Women and Children's Medical Center

    STUDY CHAIR

Central Study Contacts

Wensi Shen, MD,PhD

CONTACT

+8613631318044369353779@QQ.COM

Jenny Qiu, MD

CONTACT

+8618510386815qiukaikai0620@airdoc.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two groups for the 2 lighting lever (0.37mW and 0.6mW）for 2 groups of ages (3\~4 years old and 5\~6 years old)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 13, 2023

Study Start

March 21, 2023

Primary Completion

May 30, 2024

Study Completion

December 30, 2024

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

CN(1)