NCT05756959

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Dec 2022Dec 2027

Study Start

First participant enrolled

December 12, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 9, 2023

Status Verified

February 1, 2023

Enrollment Period

4.6 years

First QC Date

February 5, 2023

Last Update Submit

March 7, 2023

Conditions

Myopia, Progressive

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • UCVA (logMar visual acuity record)

    6 month

  • BCVA (logMar visual acuity record)

    6 month

  • OCT

    6-month

  • SFCT （um)

    6-month

Other Outcomes (1)

  • Adverse Event

    6 month

Study Arms (4)

PBM therapy + SVS

EXPERIMENTAL

Low lever red light therapy with single vision spectacles

Device: PBMDevice: Single vision spectacles

Peripheral defocus spectacles

EXPERIMENTAL

a spectacles with special design with peripheral myopic defocus to control myopia progression

Device: Peripheral defocus spectacles

PBM +Peripheral defocus spectacles

EXPERIMENTAL

Low lever red light therapy with a spectacles with special design with peripheral myopic defocus to control myopia progression

Device: PBMDevice: Peripheral defocus spectacles

Control

PLACEBO COMPARATOR

single vision spectacles only as the control

Device: Single vision spectacles

Interventions

PBMDEVICE

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

Also known as: Low lever light therapy; low intensity red light therapy; low lever laser therapy; repeated red light therapy
PBM +Peripheral defocus spectaclesPBM therapy + SVS
Peripheral defocus spectaclesDEVICE

plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina

Also known as: Myopic defocus spectacles for myopia control
PBM +Peripheral defocus spectaclesPeripheral defocus spectacles
Single vision spectaclesDEVICE

Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)

Also known as: single vision glasseses for myopia correction lenses
ControlPBM therapy + SVS

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Informed consent by the supervision of the children
  • \~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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the first people's hospital of Xuzhou

Xuzhou, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

MyopiaRefractive ErrorsEye Diseases

Study Officials

  • Yan Wang, BA

    The First People's Hospital of Xuzhou

    STUDY DIRECTOR

Central Study Contacts

Ying Li, MD, PHD

CONTACT

+8615162130727834582241@qq.com

Lei Qiao, PHD, MD

CONTACT

+15162127602

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2023

First Posted

March 7, 2023

Study Start

December 12, 2022

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 9, 2023

Record last verified: 2023-02

Locations

CN(1)