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

NCT ID: NCT06899139

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-12-31

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.

Detailed Description

Background and Rationale Myopia is a growing public health concern worldwide, especially among children, due to its progressive nature and association with severe ocular complications later in life. Orthokeratology (OK) lenses are one of the most effective non-pharmacological interventions for myopia control, reducing axial elongation by up to 63%. However, a subset of children, referred to as "ortho-k non-responders", continue to exhibit rapid axial elongation despite consistent use of OK lenses.

Repeated low-level red-light (R.L.R.L.) therapy is a novel, non-invasive intervention that has shown promise in reducing myopia progression. Preliminary studies suggest its mechanism may involve choroidal thickening, potentially complementing the effects of OK lenses. This study seeks to evaluate whether the combination of OK and R.L.R.L. offers additive benefits in myopia control for this specific population.

Study Design and Objectives This is a prospective, single-centre, randomized controlled clinical trial. The trial is being conducted at the Centro Fernández-Velázquez (Madrid, Spain) and aims to recruit 10 participants aged 8-15 years who meet specific inclusion criteria, including documented poor response to orthokeratology alone.

Participants will be randomized into two groups:

Experimental Group: OK lens + R.L.R.L. therapy (2 sessions/day, 3 minutes/session, minimum 4-hour interval) Control Group: OK lens only The primary endpoint is the change in axial length over 6 months, with the possibility of extending the intervention and monitoring for up to 12 months. Secondary endpoints include changes in refractive error, choroidal thickness, and treatment tolerance.

Measurements and Timeline Axial length will be measured using the Oculus Myopia Master. Posterior segment imaging will be performed with Topcon Maestro OCT. All evaluations are scheduled at baseline, 1 month, 3 months, and 6 months, and-if extended-at 9 and 12 months. All measurements will be performed between 9 a.m. and 11 a.m. to minimize diurnal variation.

Safety and Ethics All participants and/or their guardians will sign an informed consent prior to enrollment. The study adheres to the principles of the Declaration of Helsinki. A detailed adverse event management and reporting protocol is in place. All serious adverse events (SAEs) will be reported to the relevant ethical committees within 72 hours.

Funding and Conflicts of Interest This trial is fully self-funded by the Centro Fernández-Velázquez. The investigators declare no financial or personal conflicts of interest.

Conclusion This study will provide important preliminary evidence on the combined use of OK lenses and red-light therapy in managing progressive myopia in children who are non-responsive to orthokeratology alone. If effective, this combined approach could be incorporated into standard care protocols for high-risk paediatric patients.

Conditions

MYOPIA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

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 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.

2nd Control Arm: Orthokeratology Only

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.

Group Type: ACTIVE_COMPARATOR

Orthokeratology Lens Wear

Intervention Type: 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.

Interventions

Orthokeratology Lens Wear

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.

Intervention Type: OTHER

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

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro de Miopía Fernández-Velázquez

NETWORK

Sponsor Role: lead

Responsible Party

Fernando Fernandez Velazquez

Doctor of Optometry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro de Miopia Fernandez-Velazquez

Madrid, Madrid, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 34863776 (View on PubMed)

Other Identifiers

CMFV-SCL-2024-04

Identifier Type: -

Identifier Source: org_study_id