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The Effectiveness and Safety of Low-intensity Single-wavelength Red Light in Controlling High Myopia in Children and Adolescents：A Randomized, Controlled, Multicenter Clinical Trial

NCT05184621 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2023-11-18

No results posted yet for this study

Summary

Objective: To study the effectiveness and safety of low-intensity single wavelength red light in controlling high myopia in children and adolescents.

Methods: Subject population: Children aged 3-16 years who have high myopia. Sample size: 190 subjects were planned to be enrolled and assigned to the test or control group in a 1:1 ratio.

Conditions

  • Age 3 to 16 Years (Inclusive), Male or Female
  • Clinical Diagnosis Confirming That Myopia Has Occurred in at Least One Eye
  • The Guardian Voluntarily Signed the Subject's Informed Consent Form

Interventions

OTHER

Eyesing Redlight Instrument

Eyesing Instrument developed by Suzhou Industrial Park Zoguan Medical Equipment Co. and conventional optometry.

Sponsors & Collaborators

  • Zuoguan Medical Equipment Co., Ltd. at Suzhou Industrial Park

    collaborator UNKNOWN

  • Children's Hospital of Soochow University

    collaborator OTHER

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Shanghai East Hospital

    collaborator OTHER

  • The Children's Hospital of Zhejiang University School of Medicine

    collaborator OTHER

  • Shanxi Eye Hospital

    collaborator OTHER

  • Shanghai Eye Disease Prevention and Treatment Center

    lead OTHER

Principal Investigators

  • Haidong Zou, advanced · Shanghai Genral Hospital/Shanghai Eye disease Treatment&Prevention Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-04
Primary Completion
2023-04-15
Completion
2023-04-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05184621 on ClinicalTrials.gov