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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

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Eyesing Redlight Instrument

About this trial

This is an interventional prevention trial for Age 3 to 16 Years (Inclusive), Male or Female focused on measuring high myopia, red light, children and adolescents

Eligibility Criteria

3 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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"
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

Sites / Locations

Shanghai Eye Disease Prevention & Treatment CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

efficacy

safety

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Axial length changes

Axial length changes in the left and right eyes

Secondary Outcome Measures

change in equivalent spherical

change in equivalent spherical in both eyes

Full Information

NCT ID

NCT05184621

First Posted

December 22, 2021

Last Updated

December 22, 2021

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05184621

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

February 4, 2021 (Actual)

Primary Completion Date

February 4, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

high myopia, red light, children and adolescents

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Main efficacy indicators. 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 efficacy indicator: change in equivalent spherical lens after astigmatism (day 365±14)

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

efficacy

Arm Type

Active Comparator

Arm Description

Arm Title

safety

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Eyesing Redlight Instrument

Intervention Description

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

Primary Outcome Measure Information:

Title

Axial length changes

Description

Axial length changes in the left and right eyes

Time Frame

30± 14 days, 90± 14 days, 180± 14 days, 270± 14 days, and 365± 14 days

Secondary Outcome Measure Information:

Title

change in equivalent spherical

Description

change in equivalent spherical in both eyes

Time Frame

day 365±14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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" 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Xu, advanced

Phone

18018575251

drxuyan_2004@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haidong Zou, advanced

Organizational Affiliation

Shanghai Genral Hospital/Shanghai Eye disease Treatment&Prevention Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Eye Disease Prevention & Treatment Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haidong Zou, Ph.D

Phone

13311986528

zouhaidong@263.net

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

14985292

Citation

He M, Zeng J, Liu Y, Xu J, Pokharel GP, Ellwein LB. Refractive error and visual impairment in urban children in southern china. Invest Ophthalmol Vis Sci. 2004 Mar;45(3):793-9. doi: 10.1167/iovs.03-1051.

Results Reference

result

PubMed Identifier

10764849

Citation

Zhao J, Pan X, Sui R, Munoz SR, Sperduto RD, Ellwein LB. Refractive Error Study in Children: results from Shunyi District, China. Am J Ophthalmol. 2000 Apr;129(4):427-35. doi: 10.1016/s0002-9394(99)00452-3.

Results Reference

result

PubMed Identifier

10764851

Citation

Maul E, Barroso S, Munoz SR, Sperduto RD, Ellwein LB. Refractive Error Study in Children: results from La Florida, Chile. Am J Ophthalmol. 2000 Apr;129(4):445-54. doi: 10.1016/s0002-9394(99)00454-7.

Results Reference

result

PubMed Identifier

10764850

Citation

Pokharel GP, Negrel AD, Munoz SR, Ellwein LB. Refractive Error Study in Children: results from Mechi Zone, Nepal. Am J Ophthalmol. 2000 Apr;129(4):436-44. doi: 10.1016/s0002-9394(99)00453-5.

Results Reference

result

Learn more about this trial

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

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