MYOPIAMADRIDNCT06899139
Myopia Adjustment Using Dual-intervention: Red-Light Therapy & Innovative Design in Orthokeratology
A study testing Orthokeratology Lens Wear and 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 in people with MYOPIA, run by Centro de Miopía Fernández-Velázquez at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- MYOPIA
- What is being tested?
- Orthokeratology Lens Wear and 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Orthokeratology Lens Wear, 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
- Keywords
- Myopia, Orthokeratology, Red-Light Therapy, RLRL
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthokeratology Lens WearOther
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.
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 noDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Orthokeratology Lens Wear |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Change in Refractive Error (Spherical Equivalent) at 6 and 12 Months
Change in spherical equivalent refraction (in dioptres) from baseline to 6 and 12 months will be assessed via cycloplegic autorefraction and subjective refraction to monitor refractive progression.
Measured: 12 months
Change in Subfoveal Choroidal Thickness at 6 and 12 Months
Subfoveal choroidal thickness will be measured using spectral-domain OCT (Topcon Maestro) at baseline, 6 months, and 12 months to assess structural retinal changes potentially associated with treatment efficacy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MYOPIAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Miopía Fernández-Velázquez
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Fernando Fernandez Velazquez, Centro de Miopía Fernández-Velázquez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899139
- Sponsor's protocol ID
- CMFV-SCL-2024-04
- Acronym
- MADRID
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared for this study due to the small sample size, the exploratory nature of the investigation, and privacy considerations. Future larger-scale studies may consider data sharing under appropriate governance.
Publications
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.
PubMed 34863776
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopia Adjustment Using Dual-intervention: Red-Light Therapy & Innovative Design in Orthokeratology
- ClinicalTrials.gov ID
- NCT06899139
- Acronym / sponsor ID
- MADRID / CMFV-SCL-2024-04
- Conditions
- MYOPIA
- Keywords
- Myopia, Orthokeratology, Red-Light Therapy, RLRL
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centro de Miopía Fernández-VelázquezResearch network
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm Title: Orthokeratology + Red-Light Therapy Control Arm Title: Orthokeratology Only | Experimental | 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 no1st 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. |
| 2nd Control Arm: Orthokeratology Only | Active comparator | Other: Orthokeratology Lens WearParticipants 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthokeratology Lens WearOrthokeratology 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. | Other | 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 noDescription: 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. | Device | Experimental Arm Title: Orthokeratology + Red-Light Therapy Control Arm Title: Orthokeratology Only |
Primary outcome
Change in Axial Length
Time frame: 12 months
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.
2 secondary outcomes
Change in Refractive Error (Spherical Equivalent) at 6 and 12 Months
Time frame: 12 months
Change in Subfoveal Choroidal Thickness at 6 and 12 Months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Background: PubMed 34863776Jiang 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared for this study due to the small sample size, the exploratory nature of the investigation, and privacy considerations. Future larger-scale studies may consider data sharing under appropriate governance.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthokeratology Lens Wear and 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 in people with MYOPIA, run by Centro de Miopía Fernández-Velázquez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Axial Length (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06899139, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.