Myopia Control Combined PBM With Myopic Defocus Lens in Children

Myopia Control Combined PBM With Myopic Defocus Lens in Children: Double-blind RCT for 6 Month

To study the efficacy of myopi control with two methods: low lever red light and peripheral defocus spectacles with four groups and design with prospective, double-blind, randimized, and with control for 6 month.

Study Overview

• Status: Recruiting
• Conditions: Myopia, Progressive
• Intervention / Treatment: Device: PBM; Device: Single vision spectacles; Device: Peripheral defocus spectacles

Detailed Description

myopic children with age from 6 ~13 years old. And refraction from -0.50D~-5.50D.

The red light is low lever laser therapy at wavelength of 650nm.

• Study Type: Interventional
• Enrollment (Anticipated): 304
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying Li, MD, PHD; Phone Number: +8615162130727; Email: 834582241@qq.com
• Study Contact Backup: Name: Lei Qiao, PHD, MD; Phone Number: +15162127602

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 210000
      • Recruiting
      • The First People's Hospital of Xuzhou
      • Contact: Ying Li, MD.Ph.D.; Phone Number: +8615162130727; Email: 834582241@qq.com
      • Sub-Investigator: Weiming Yang, MD. PhD
      • Principal Investigator: Xiaoying Wang, MD. PhD.
      • Principal Investigator: Xingtao Zhou, MD. PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Informed consent by the supervision of the children
• 6~13 years old (including both the 6 and 13)
• SE range: -0.50~-5.50D
• Astigmatism <=2.00D
• BCVA >=0.8
• Anisometropia <=1.50D
• Confirmed to no use of other myopia control intervention

Exclusion Criteria:

• Ocular lesions to effect vision or diseases (such as cataract, glaucoma, marcular pathology, cornea lesions, uveitis, retina detachment, congential opitc abnormal and etc.)
• Halo, glare, toutic, ADHD, psoriasis
• Systom disease: immune disease, central nerve system, Down syndrome, asthma, severe cardiopulmonary abnormal, severe liver and renal dysfunction.
• Squint, ocular lesion or acute imflammation.
• Other myopia control interventions within recent 3 month such as atropine, device, orthokeratology, multi-focus soft lens, multi-function spectacles.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PBM therapy + SVS; Low lever red light therapy with single vision spectacles	Device: PBM; PBM, is a low intensity red light at wavelength of 650nm; Peripheral defocus spectacels is a peripheral design glasseses for correct myopia and control myopia; Other Names: Low lever light therapy; low intensity red light therapy; low lever laser therapy; repeated red light therapy; Device: Single vision spectacles; Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction); Other Names: single vision glasseses for myopia correction lenses
Experimental: Peripheral defocus spectacles; a spectacles with special design with peripheral myopic defocus to control myopia progression	Device: Peripheral defocus spectacles; plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina; Other Names: Myopic defocus spectacles for myopia control
Experimental: PBM +Peripheral defocus spectacles; Low lever red light therapy with a spectacles with special design with peripheral myopic defocus to control myopia progression	Device: PBM; PBM, is a low intensity red light at wavelength of 650nm; Peripheral defocus spectacels is a peripheral design glasseses for correct myopia and control myopia; Other Names: Low lever light therapy; low intensity red light therapy; low lever laser therapy; repeated red light therapy; Device: Peripheral defocus spectacles; plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina; Other Names: Myopic defocus spectacles for myopia control
Placebo Comparator: Control; single vision spectacles only as the control	Device: Single vision spectacles; Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction); Other Names: single vision glasseses for myopia correction lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
axial length (mm)	Axial length changes at follow-up of 6 month from baseline will be measured by IOLmaster 500 at the same site by the same examiner with the mean values of 5 times measurements at either time. Changes in axial length (mm) without cycloplegia are to be measured by IOLmaster(Carl Zeiss). Five measurements will be taken and then averaged.	6 month
SE (Diopter, D)	changes of cycloplegic spherical equivalent from baseline will be measured under cycloplegic refraction by autorefractor. Five measured by the same autorefractor are to be obtained for each eye.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UCVA (logMar visual acuity record)	Uncorrected visual acuity will be measured under 5-meter distance logMar Visual acuity chart without any aid （including the spectacles or contact lens) at baseline and at follow-up	6 month
BCVA (logMar visual acuity record)	Best corrected visual acuity will be measured under the same 5-meter distance logMar Visual acuity as the UCVA both at baseline and at follow-up.	6 month
OCT	Opitcal coherence tomography(OCT) record The marcular sturcture and image scanned by the optical coherent topography will be measured by linear scan at the marcular by the same Optical coherence tomography with the same examiner and the same instrument both at baseline and at follow-up	6-month
SFCT （um)	Sub-forveal choroidal thickness will be measured with the same software in the same Optical coherence tomography (OCT) at the location from the foveal center manually	6-month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event	Any adverse event reported by subjects or doctors related or un-related to the product during the whole study period	6 month

Collaborators and Investigators

• Sponsor: Beijing Airdoc Technology Co., Ltd.
• Collaborators: The First People's Hospital of Xuzhou
• Investigators: Study Director: Yan Wang, BA, The First People's Hospital of Xuzhou

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Anticipated): August 1, 2027
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: February 5, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative
• Other Study ID Numbers: Xuzhou First People's Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No