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 | Completed DMC

• 1 other identifier: ShanghaiEye
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

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

Keywords

high myopia; red light; children and adolescents

Outcome Measures

Primary Outcomes (1)

• Axial length changes

  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 Outcomes (1)

• change in equivalent spherical

  day 365±14

Study Arms (2)

efficacy

ACTIVE COMPARATOR

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

safety

ACTIVE COMPARATOR

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

Interventions

Eyesing Redlight Instrument OTHER

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

efficacy; safety

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead
• Zuoguan Medical Equipment Co., Ltd. at Suzhou Industrial Park: collaborator
• Children's Hospital of Soochow University: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai East Hospital: collaborator
• The Children's Hospital of Zhejiang University School of Medicine: collaborator
• Shanxi Eye Hospital: collaborator

Study Sites (1)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (5)

• 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.

  PMID: 14985292 RESULT

• 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.

  PMID: 10764849 RESULT

• 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.

  PMID: 10764851 RESULT

• 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.

  PMID: 10764850 RESULT

• Xu Y, Cui L, Kong M, Li Q, Feng X, Feng K, Zhu H, Cui H, Shi C, Zhang J, Zou H. Repeated Low-Level Red Light Therapy for Myopia Control in High Myopia Children and Adolescents: A Randomized Clinical Trial. Ophthalmology. 2024 Nov;131(11):1314-1323. doi: 10.1016/j.ophtha.2024.05.023. Epub 2024 Jun 6.

  PMID: 38849054 DERIVED

Study Officials

• Haidong Zou, advanced

  Shanghai Genral Hospital/Shanghai Eye disease Treatment&Prevention Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Doctors

Model Details: 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)

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 11, 2022
• Study Start: February 4, 2021
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)