Myopia Adjustment Using Dual-intervention: Red-Light Therapy & Innovative Design in Orthokeratology

NCT06899139 | Active Not Recruiting DMC

• 1 other identifier: CMFV-SCL-2024-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial investigates the efficacy of combining orthokeratology (OK) lenses with repeated low-level red-light (R.L.R.L.) therapy in slowing the progression of myopia in children classified as ortho-k non-responders. The MADRID study is a single-centre, prospective, randomized controlled trial conducted at the Centro Fernández-Velázquez in Madrid, Spain. Participants aged 8 to 15 years will be randomly assigned to either a control group (OK lenses only) or an experimental group (OK lenses + R.L.R.L. therapy). The primary objective is to assess the potential additive effect of R.L.R.L. therapy on axial length control over a 6 to 12-month follow-up period. All participants will undergo ocular biometry and posterior segment OCT at regular intervals. The study is fully self-funded by the institution and adheres to rigorous ethical and safety standards.

Conditions

MYOPIA

Keywords

Myopia; Orthokeratology; Red-Light Therapy; RLRL

Outcome Measures

Primary Outcomes (1)

• Change in Axial Length

  Axial length (in millimetres) will be measured using the Myopia Master (Oculus) at baseline and at 6 and 12 months to evaluate the progression of myopia. Measurements will be conducted between 9:00-11:00 a.m. to reduce diurnal variation.

  12 months

Secondary Outcomes (2)

• Change in Refractive Error (Spherical Equivalent) at 6 and 12 Months

  12 months

• Change in Subfoveal Choroidal Thickness at 6 and 12 Months

  12 months

Study Arms (2)

Experimental Arm Title: Orthokeratology + Red-Light Therapy Control Arm Title: Orthokeratology Only

EXPERIMENTAL

1st Experimental Arm: Orthokeratology + Red-Light Therapy Participants in this arm will wear orthokeratology (OK) lenses overnight for at least 8 hours per night and undergo repeated low-level red-light (R.L.R.L.) therapy twice daily. Each R.L.R.L. session will last up to 3 minutes, with a minimum interval of 4 hours between sessions. The intervention period will last 6 months, with a potential extension to 12 months based on clinical assessment.

Device: Repeated Low-Level Red-Light Therapy Intervention Type: Device Description: Participants in the experimental group will receive repeated low-level red-light (R.L.R.L.) therapy twice daily using a no

2nd Control Arm: Orthokeratology Only

ACTIVE COMPARATOR

Participants in this arm will wear orthokeratology (OK) lenses overnight for at least 8 hours per night. They will not receive red-light therapy. The intervention period will last 6 months, with a potential extension to 12 months based on clinical assessment.

Other: Orthokeratology Lens Wear

Interventions

Orthokeratology Lens Wear OTHER

Orthokeratology Lens Wear Intervention Type: Device Description: Participants will wear gas-permeable orthokeratology (OK) lenses overnight for a minimum of 8 hours per night. Lenses are designed to reshape the cornea temporarily to reduce refractive error and slow axial elongation. This intervention is administered to both the experimental and control groups.

2nd Control Arm: Orthokeratology Only

Repeated Low-Level Red-Light Therapy Intervention Type: Device Description: Participants in the experimental group will receive repeated low-level red-light (R.L.R.L.) therapy twice daily using a no DEVICE

Description: Participants in the experimental group will receive repeated low-level red-light (R.L.R.L.) therapy twice daily using a non-invasive light-emitting device. Each session will last no more than 3 minutes, with a minimum interval of 4 hours between sessions. The therapy is administered under parental supervision and aims to enhance myopia control in conjunction with orthokeratology.

Experimental Arm Title: Orthokeratology + Red-Light Therapy Control Arm Title: Orthokeratology Only

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children aged 8 to 15 years. Intention to undergo orthokeratology (OK) lens treatment. Spherical equivalent refractive error between -1.00 and -4.00 diopters in either eye.
• Astigmatism no greater than 1.50 D in either eye. Best corrected visual acuity (BCVA) of 25/25 or better in both eyes. Birth weight of at least 1500 g. Classified as ortho-k non-responders: continued OK use with persistent rapid myopia progression.
• Willingness of child and legal guardian to participate and attend follow-up visits.
• Signed informed consent by parent or guardian.

You may not qualify if:

• cular conditions such as strabismus, amblyopia, cataract, or ptosis. Previous use of OK lenses or atropine for myopia control. Contraindications to atropine (e.g., known allergy, cardiovascular disease, epilepsy).
• Ocular contraindications to OK lens wear (e.g., inflammation, infection). Systemic diseases that may affect ocular growth (e.g., Down syndrome, Marfan syndrome).
• Any other ocular disease that could interfere with study outcomes.

Sponsors & Collaborators

• Centro de Miopía Fernández-Velázquez: lead

Study Sites (1)

Centro de Miopia Fernandez-Velazquez

Madrid, Madrid, 28029, Spain

Location

Related Publications (1)

• Jiang Y, Zhu Z, Tan X, Kong X, Zhong H, Zhang J, Xiong R, Yuan Y, Zeng J, Morgan IG, He M. Effect of Repeated Low-Level Red-Light Therapy for Myopia Control in Children: A Multicenter Randomized Controlled Trial. Ophthalmology. 2022 May;129(5):509-519. doi: 10.1016/j.ophtha.2021.11.023. Epub 2021 Dec 1.

  PMID: 34863776 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Optometry

Model Details: This is a two-arm, parallel-group randomized controlled trial. Participants will be allocated in a 1:1 ratio to either the experimental group (Orthokeratology + Repeated Low-Level Red-Light Therapy) or the control group (Orthokeratology only). Randomization will be computer-generated and stratified to ensure balanced group sizes. The intervention will be applied continuously for 6 months, with a possible extension to 12 months based on interim evaluation.

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 27, 2025
• Study Start: March 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)