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

November 15, 2023 updated by: XuYan, Shanghai Eye Disease Prevention and Treatment Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Design: The trial was a randomized, controlled, multicenter clinical trial. A total of 190 children aged 3-16 years with high myopia were selected and divided into 95 cases in the test group and 95 cases in the control group. The test group was treated with the Eyesing Instrument developed by Suzhou Industrial Park Zoguan Medical Equipment Co. and conventional optometry. The safety and efficacy of the low-energy laser device in the test group were evaluated by comparing the changes in myopia between the two groups during the observation period. Subjects were screened after signing the informed consent form (performed as early as 7 days before the randomization), and the examination used for screening could use the results of eye examinations performed within 1 week at our hospital, and they were enrolled after confirming that they met the inclusion criteria. On the same day, the grouping was done by randomization, and the glasses were prescribed or the glasses were prescribed in combination with the device according to the grouping results. Visits were performed at 30± 14 days, 90± 14 days, 180± 14 days, 270± 14 days, and 365± 14 days

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Shanghai Eye Disease Prevention & Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. age 3 to 16 years (inclusive), male or female
  2. clinical diagnosis confirming that myopia has occurred in at least one eye.

  3. the guardian voluntarily signed the "Subject's Informed Consent Form"

    Exclusion Criteria:

    • history of photosensitivity, glaucoma, glaucoma syndrome, high intraocular pressure, macular lesion or injury in the fundus ② corneal curvature examination, the average K value of the anterior surface of the cornea ≥ 45; ③ combined with heart, liver, kidney and other systemic diseases and prior.

      • Combination of cardiac, hepatic, renal, and other systemic diseases and congenital myopia; ④ Combination of ocular trauma and congenital myopia.

        ④ Combined with ocular trauma and chronic ocular diseases such as apparently oblique or operated eyes, atopic keratoconjunctivitis, etc.; ⑤ Previous presence of entropion.

        ⑤ Those with previous entropion and other eye diseases such as severe corneal and conjunctival infections; ⑥ Those with combined neurological diseases and other eye diseases.

        (6) Those with combined neurological disorders and allergies or contraindications to atropine drugs or other therapeutic drugs; (7) Albinism and psoriasis.

        (7) Patients with albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, diabetes mellitus, and other immune system and systemic diseases; (8) Epilepsy, psychiatric disorders.

        ⑧ epilepsy, mental disorders who cannot communicate normally.

        • Previously treated with other treatments to control the development of myopia such as anticholinergic drugs such as atropine within 3 months, or involved in other functional
        • Previously treated with other treatments to control the development of myopia, such as anticholinergic drugs like atropine within 3 months, or involved in other studies related to functional frame lenses, multifocal soft lenses, etc.

    Other conditions judged by the investigator to be unsuitable for participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: efficacy
Including Primary outcome: changes in axial length of the eye. Secondary outcome: Equivalent spherical lens variation Other indicators: ① Changes in visual acuity with lenses, corrected visual acuity, and intraocular pressure.② Observation of changes in corneal thickness, anterior chamber depth, ciliary body thickness, and crystal thickness.Observation of fundus tissue structure of macula and peri-optic disc area. Observation of fundus choroidal/retinal thickness.Adherence index: frequency of device use.
Other: Eyesing Redlight Instrument
Eyesing Instrument developed by Suzhou Industrial Park Zoguan Medical Equipment Co. and conventional optometry.
Active Comparator: safety

Description of safety parameters: Adverse events, device defects during the test.

Method and time selection for evaluation, recording, and analysis of safety parameters. Adverse events and device defects were recorded from the beginning of each subject's enrollment to the end of the group for evaluation. Safety indicators:① Incidence of allergic reactions.② Posterior image time more than 5 minutes.③ The decrease of near vision.④ The grade of side effects such as self-induced photophobia and blurred vision.⑤ Elevated intraocular pressure, headache, nausea, and vomiting, etc.
Other: Eyesing Redlight Instrument
Eyesing Instrument developed by Suzhou Industrial Park Zoguan Medical Equipment Co. and conventional optometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial length changes
Time Frame: 30± 14 days, 90± 14 days, 180± 14 days, 270± 14 days, and 365± 14 days
Axial length changes in the left and right eyes
30± 14 days, 90± 14 days, 180± 14 days, 270± 14 days, and 365± 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in equivalent spherical
Time Frame: day 365±14
change in equivalent spherical in both eyes
day 365±14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Collaborators

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai East Hospital
Children's Hospital of Soochow University
The Children's Hospital of Zhejiang University School of Medicine
Shanxi Eye Hospital
Zuoguan Medical Equipment Co., Ltd. at Suzhou Industrial Park

Investigators

  • Principal Investigator: Haidong Zou, advanced, Shanghai Genral Hospital/Shanghai Eye disease Treatment&Prevention Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2021

Primary Completion (Actual)

April 15, 2023

Study Completion (Actual)

April 15, 2023

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiEye

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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