Repeated Low-Level Red-Light Therapy and Orthokeratology in Fast-progressing Myopia Control

The Multicenter Randomized Clinical Trial of Fast-progressing Myopia Control Using Repeated Low-Level Red-Light Therapy and Orthokeratology

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.

Study Overview

• Status: Recruiting
• Conditions: Eye Diseases; Refractive Errors; Myopia, Progressive
• Intervention / Treatment: Device: Ortho-k lenses; Device: RLRL

Detailed Description

Myopia constitutes a major threat to personal health globally for its increased prevalence. Moreover, its dose-related association with irreversible blindness complications such as myopic macular degeneration have been demonstrated. It is crucial to look for effective ways to control myopia in children to reduce risk of myopic pathologies in later life.

Orthokeratology (ortho-k) is the first-line optical method in myopia control, resulting in slowing axial elongation by 43-63%. However, results after ortho-k treatment vary among individuals. Methods with more accurate efficacy and wider application to slowing down myopia progression, especially for myopia with limited ortho-k response, are still urgently required.

Repeated low-level red-light (RLRL) therapy is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. Our previous clinical study suggested RLRL could effectively retard myopia progression without clinically observable side effects.

The purpose of this study is to evaluate the adjunctive effect of RLRL and ortho-k on myopia control in ortho-k non-responders using a multicenter randomized controlled trial design. Ortho-k non-responders are defined as who have continuously undergone ortho-k treatment but were still experiencing fast myopia progression. The subjects will be randomly assigned to either experimental group (RLRL and ortho-k) or control group (ortho-k). Their axial length will be monitored over one year. Changes in axial length in the two groups will be compared.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiao Yang, Professor; Phone Number: +86-020-87330348; Email: 1394392659@qq.com

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Recruiting
      • The Second People's Hospital of Foshan
      • Contact: Xiangbin Kong, PhD
      • Contact: Fabiao Li, MBSS
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Xiao Yang, PhD; Phone Number: +86-020-87330348; Email: 1394392659@qq.com
      • Principal Investigator: Xiao Yang, PhD
      • Principal Investigator: Mingguang He, PhD
  • Tianjin
    • Tianjin, Tianjin, China, 300384
      • Recruiting
      • Tianjin Medical University Eye Center
      • Contact: Ruihua Wei, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Start to receive ortho-k treatment one year ago.
2. Age at enrolment: 8-13 years.
3. 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.
4. 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.
5. Parents' understanding and acceptance of random allocation of grouping

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ortho-k; Participants will continue to use ortho-k lenses alone.	Device: Ortho-k lenses; Ortho-k lenses will be administered nightly.; Other Names: Orthokeratology lens
Experimental: RLRL+Ortho-k; Participants will be treated with RLRL twice a day in addition to ortho-k lenses.	Device: Ortho-k lenses; Ortho-k lenses will be administered nightly.; Other Names: Orthokeratology lens; Device: RLRL; 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.; Other Names: Repeated low-level red-light therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in other ocular parameters	The Lenstar is used to measure ocular parameters (e.g., cornea thickness, lens thickness). Change of each parameter is characterized as the difference between its 12-month follow-up visit and baseline values.	12 months
Incidence of treatment-emergent adverse events	Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over the study period for subjects in both arms.	12 months

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Collaborators: The Second People's Hospital of Foshan; Tianjin Medical University Eye Center
• Investigators: Principal Investigator: Xiao Yang, Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 13, 2021
• Last Update Submitted That Met QC Criteria: August 11, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Refractive Errors; Eye Diseases; Myopia; Myopia, Degenerative
• Other Study ID Numbers: 2020KYPJ156

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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