NCT04722874

Brief Summary

The purpose of this multicenter randomized clinical trial is to evaluate the adjunctive effect of repeated low-level red-light therapy (RLRL) and orthokeratology (ortho-k) on myopia control in ortho-k non-responders who have undergone ortho-k treatment but were still experiencing fast myopia progression.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 14, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

January 21, 2021

Last Update Submit

August 11, 2021

Conditions

Myopia, ProgressiveRefractive ErrorsEye Diseases

Outcome Measures

Primary Outcomes (1)

  • Axial length change

    Axial length change (mm) is characterized as the difference between 12-month follow-up visit and baseline values. The Lenstar is used to measure axial length (mm).

    12 months

Secondary Outcomes (2)

  • Changes in other ocular parameters

    12 months

  • Incidence of treatment-emergent adverse events

    12 months

Study Arms (2)

Ortho-k

ACTIVE COMPARATOR

Participants will continue to use ortho-k lenses alone.

Device: Ortho-k lenses

RLRL+Ortho-k

EXPERIMENTAL

Participants will be treated with RLRL twice a day in addition to ortho-k lenses.

Device: Ortho-k lensesDevice: RLRL

Interventions

Ortho-k lensesDEVICE

Ortho-k lenses will be administered nightly.

Also known as: Orthokeratology lens
Ortho-kRLRL+Ortho-k
RLRLDEVICE

RLRL will be performed twice a day with an interval of at least 4 hours, each treatment last 3 minutes. Nightly treatment should be performed at least 30 minutes before ortho-k lens insertion.

Also known as: Repeated low-level red-light therapy
RLRL+Ortho-k

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Start to receive ortho-k treatment one year ago.
  • Age at enrolment: 8-13 years.
  • Ortho-k non-responders: those who have continuously undergone ortho-k treatment but were still experiencing fast myopia progression (annual axial elongation equal to or more than 0.5 mm) in the past one year in at least one eye.
  • Before wearing ortho-k lenses, spherical equivalent refractions (SERs) ranging from -1.00 to -5.00 Dioptres (D) and astigmatism less than -1.5 D in both eyes, anisometropia less than 1.5 D, and best corrected logMAR visual acuity (VA) equal to or better than 0 in both eyes.
  • Parents' understanding and acceptance of random allocation of grouping

You may not qualify if:

  • Strabismus and binocular vision abnormalities.
  • Ocular or systemic abnormalities.
  • Prior treatment of myopia control in the past three months, e.g. drugs, progressive addition lenses, bifocal lenses, etc.
  • Other contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Second People's Hospital of Foshan

Foshan, Guangdong, 528000, China

RECRUITING

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Tianjin Medical University Eye Center

Tianjin, Tianjin Municipality, 300384, China

RECRUITING

Related Publications (1)

  • Xiong R, Wang W, Tang X, He M, Hu Y, Zhang J, Du B, Jiang Y, Zhu Z, Chen Y, Zhang S, Kong X, Wei R, Yang X, He M. Myopia Control Effect of Repeated Low-Level Red-Light Therapy Combined with Orthokeratology: A Multicenter Randomized Controlled Trial. Ophthalmology. 2024 Nov;131(11):1304-1313. doi: 10.1016/j.ophtha.2024.05.015. Epub 2024 May 18.

    PMID: 38763303DERIVED

MeSH Terms

Conditions

Myopia, DegenerativeRefractive ErrorsEye Diseases

Condition Hierarchy (Ancestors)

Myopia

Study Officials

  • Xiao Yang, Professor

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Yang, Professor

CONTACT

+86-020-873303481394392659@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2021

First Posted

January 25, 2021

Study Start

March 14, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

August 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

Locations

CN(3)