MyopiaNCT07748546
The Rebound Effect on Repeated Low-Level Red Light Therapy for Myopia
A study testing Repeated low-level red light (RLRL) therapy in people with Myopia and Randomized Controlled Trial (RCT), run by The First Affiliated Hospital of Anhui Medical University.
Trial summary
Myopia is a global public health issue, projected to affect 49.8% of the world population by 2050, increasing risks of cataracts, glaucoma, macular degeneration, and retinal detachment. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Myopia, Randomized Controlled Trial (RCT)
- What is being tested?
- Repeated low-level red light (RLRL) therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 15 Jul 2028
- 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 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8 to 16 years old
- Rceived continuous RLRL treatment for 1 year (±1 month) without interruption.
- Diagnosed with myopia (ciliary muscle paralysis SER ≥ -0.50 D), astigmatism ≤ 2.50 D, anisometropia ≤ 1.50 D, and bilateral best corrected visual acuity (BCVA) ≥ Snellen 20/20 before receiving RLRL treatment.
- The consent of the guardian and the consent of the participant.
Who cannot join
- History of any ophthalmic surgery or ocular diseases (e.g., glaucoma, retinal disorders).
- Systemic diseases that affect vision or eye health (e.g., diabetes). After discontinuing RLRL treatment, other myopia control interventions other than monocular glasses should be employed (including atropine, orthokeratology lenses, defocused/DOT lenses, etc.).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Rebound Effect on Repeated Low-Level Red Light Therapy for Myopia: A Randomized Controlled Clinical Trial
Myopia is a global public health issue, projected to affect 49.8% of the world population by 2050, increasing risks of cataracts, glaucoma, macular degeneration, and retinal detachment. Repeated low-level red light (RLRL) therapy has shown promising myopia control in 12-month trials, reducing axial elongation by 69.4% and refractive progression by 76.6% versus spectacles, outperforming 0.01% atropine and benefiting orthokeratology poor responders. However, two-year data indicate declining efficacy in the second year and a rebound effect upon discontinuation, with progression rates matching untreated controls. This study enrolls participants who completed one year of continuous RLRL therapy to evaluate rebound effects on axial length and spherical equivalent refractive power among those who discontinue, gradually reduce, or continue treatment. Findings will inform strategies to optimize long-term RLRL protocols and mitigate post-treatment rebound.
Read the detailed description
Myopia is a public health issue of global concern, with its incidence and severity increasing annually, particularly among children and adolescents. Projections indicate that by 2050, the global prevalence of myopia will reach as high as 49.8%, with the prevalence of high myopia reaching 9.8% .With the rising prevalence of myopia, the risk of myopia-related complications has increased significantly, including cataracts, glaucoma, myopic macular degeneration, and retinal detachment. Without proper management, these conditions can lead to severe visual impairment and substantial societal burdens. Therefore, preventing and slowing the onset and progression of myopia has become a critical strategy in myopia control efforts.
Repeated low-level red light (RLRL) therapy is an emerging treatment modality for myopia control. In a 12-month multicenter randomized clinical trial, the RLRL group demonstrated a 69.4% reduction in axial length elongation and a 76.6% decrease in myopic refractive progression compared to the single-vision spectacle (SVS) group. Furthermore, RLRL therapy showed superior efficacy in patients with high myopia, achieving an axial length reduction of over 0.05 mm in 53.3%-59% of cases.Comparative studies on the efficacy of atropine in controlling myopia demonstrated that, after 12 months of use, the RLRL therapy significantly outperformed 0.01% atropine in controlling axial length.In myopic patients who still exhibit poor control of axial length despite wearing orthokeratology lenses, combined use of RLRL therapy significantly inhibits axial growth.
Given that myopia typically progresses continuously during childhood, Xiong et al. investigated the long-term efficacy and safety of RLRL therapy over a period exceeding two years. The results demonstrated good tolerability of RLRL therapy, with an efficacy rate of 75% in terms of axial length reduction and myopic refractive control after two years of treatment; however, the therapeutic efficacy declined in the second year compared to the first year.Additionally, similar to other myopia intervention strategies, a rebound effect was observed in patients who discontinued RLRL treatment after one year; in these patients, their myopia progression rate during the second year was comparable to the progression level observed in the SVS group during its first year.
To further investigate the long-term efficacy of RLRL treatment and rebound effects after treatment discontinuation, as well as to explore strategies for mitigating these rebound effects, this study focused on participants who received continuous RLRL therapy for one year. It examined the rebound effects in axial length (AL) and spherical equivalent refractive power (SER) among participants who discontinued or gradually reduced RLRL treatment compared to those who continued treatment.
- Conditions
- Myopia, Randomized Controlled Trial (RCT)
- Being tested
- Repeated low-level red light (RLRL) therapy
- Keywords
- myopia, randomized controlled trial, therapy
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated low-level red light (RLRL) therapyDevice
Repeated low-level red light (RLRL) therapy is an emerging treatment modality for myopia control. The participants were randomly assigned to three groups: the continued RLRL treatment group (RLRL-C), the discontinued RLRL treatment group (RLRL-I), and the gradually reduced RLRL treatment group (RLRL-T).
| Study group | Role | What they receive |
|---|---|---|
| the continued RLRL treatment group(RLRL-C) | Active comparator | The pediatric participants had received continuous Repeated low-level red light(RLRL) treatment for one year and continue to receive RLRL treatment for one more year. Receives: Device: Repeated low-level red light (RLRL) therapy |
| the discontinued RLRL treatment group (RLRL-I) | Experimental | The pediatric participants had received continuous Repeated low-level red light(RLRL) treatment for one year and discontinue RLRL treatment for one year. Receives: Device: Repeated low-level red light (RLRL) therapy |
| the gradually reduced RLRL treatment group (RLRL-T) | Experimental | The pediatric participants had received continuous Repeated low-level red light(RLRL) treatment for one year and gradually reduce the RLRL treatment for one year(First month: twice daily, for 5 days per week;Second month: Once daily, for 5 days per week;Third month: once daily, for 3 days per week). Receives: Device: Repeated low-level red light (RLRL) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length(AL)
Change from baseline in Axial length [Unit of Measure:mm]
Measured: Baseline, 6 months and12 months.
Secondary outcomes (4)
Change in Spherical Equivalent Refraction (SER)
Mean change from baseline in spherical equivalent refraction [ Unit of Measure: Diopters (D) ]
Measured: Baseline, 6 Months, 12 Months
Best-Corrected Visual Acuity (BCVA)
Change from baseline in best-corrected visual acuity measured using the ETDRS chart [Unit of Measure: LogMAR]
Measured: Baseline, 6 Months, 12 Months
corneal curvature
Change from baseline in mean corneal curvature (K-readings) [Unit of Measure: Diopters]
Measured: Baseline, 6 Months, 12 Months
Anterior Chamber Depth (ACD)
Change from baseline in anterior chamber depth (Unit of Measure：mm)
Measured: Baseline,6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lixia Feng, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748546
- Sponsor's protocol ID
- KY2026-03-88
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rebound Effect on Repeated Low-Level Red Light Therapy for Myopia: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07748546
- Acronym / sponsor ID
- KY2026-03-88
- Conditions
- Myopia, Randomized Controlled Trial (RCT)
- Keywords
- myopia, randomized controlled trial, therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 5 Aug 2026 (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.
Myopia is a global public health issue, projected to affect 49.8% of the world population by 2050, increasing risks of cataracts, glaucoma, macular degeneration, and retinal detachment. Repeated low-level red light (RLRL) therapy has shown promising myopia control in 12-month trials, reducing axial elongation by 69.4% and refractive progression by 76.6% versus spectacles, outperforming 0.01% atropine and benefiting orthokeratology poor responders. However, two-year data indicate declining efficacy in the second year and a rebound effect upon discontinuation, with progression rates matching untreated controls. This study enrolls participants who completed one year of continuous RLRL therapy to evaluate rebound effects on axial length and spherical equivalent refractive power among those who discontinue, gradually reduce, or continue treatment. Findings will inform strategies to optimize long-term RLRL protocols and mitigate post-treatment rebound.
Detailed description
Myopia is a public health issue of global concern, with its incidence and severity increasing annually, particularly among children and adolescents. Projections indicate that by 2050, the global prevalence of myopia will reach as high as 49.8%, with the prevalence of high myopia reaching 9.8% .With the rising prevalence of myopia, the risk of myopia-related complications has increased significantly, including cataracts, glaucoma, myopic macular degeneration, and retinal detachment. Without proper management, these conditions can lead to severe visual impairment and substantial societal burdens. Therefore, preventing and slowing the onset and progression of myopia has become a critical strategy in myopia control efforts.
Repeated low-level red light (RLRL) therapy is an emerging treatment modality for myopia control. In a 12-month multicenter randomized clinical trial, the RLRL group demonstrated a 69.4% reduction in axial length elongation and a 76.6% decrease in myopic refractive progression compared to the single-vision spectacle (SVS) group. Furthermore, RLRL therapy showed superior efficacy in patients with high myopia, achieving an axial length reduction of over 0.05 mm in 53.3%-59% of cases.Comparative studies on the efficacy of atropine in controlling myopia demonstrated that, after 12 months of use, the RLRL therapy significantly outperformed 0.01% atropine in controlling axial length.In myopic patients who still exhibit poor control of axial length despite wearing orthokeratology lenses, combined use of RLRL therapy significantly inhibits axial growth.
Given that myopia typically progresses continuously during childhood, Xiong et al. investigated the long-term efficacy and safety of RLRL therapy over a period exceeding two years. The results demonstrated good tolerability of RLRL therapy, with an efficacy rate of 75% in terms of axial length reduction and myopic refractive control after two years of treatment; however, the therapeutic efficacy declined in the second year compared to the first year.Additionally, similar to other myopia intervention strategies, a rebound effect was observed in patients who discontinued RLRL treatment after one year; in these patients, their myopia progression rate during the second year was comparable to the progression level observed in the SVS group during its first year.
To further investigate the long-term efficacy of RLRL treatment and rebound effects after treatment discontinuation, as well as to explore strategies for mitigating these rebound effects, this study focused on participants who received continuous RLRL therapy for one year. It examined the rebound effects in axial length (AL) and spherical equivalent refractive power (SER) among participants who discontinued or gradually reduced RLRL treatment compared to those who continued treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the continued RLRL treatment group(RLRL-C) | Active comparator | Device: Repeated low-level red light (RLRL) therapyThe pediatric participants had received continuous Repeated low-level red light(RLRL) treatment for one year and continue to receive RLRL treatment for one more year. |
| the discontinued RLRL treatment group (RLRL-I) | Experimental | Device: Repeated low-level red light (RLRL) therapyThe pediatric participants had received continuous Repeated low-level red light(RLRL) treatment for one year and discontinue RLRL treatment for one year. |
| the gradually reduced RLRL treatment group (RLRL-T) | Experimental | Device: Repeated low-level red light (RLRL) therapyThe pediatric participants had received continuous Repeated low-level red light(RLRL) treatment for one year and gradually reduce the RLRL treatment for one year(First month: twice daily, for 5 days per week;Second month: Once daily, for 5 days per week;Third month: once daily, for 3 days per week). |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 8 to 16 years old
- Rceived continuous RLRL treatment for 1 year (±1 month) without interruption.
- Diagnosed with myopia (ciliary muscle paralysis SER ≥ -0.50 D), astigmatism ≤ 2.50 D, anisometropia ≤ 1.50 D, and bilateral best corrected visual acuity (BCVA) ≥ Snellen 20/20 before receiving RLRL treatment.
- The consent of the guardian and the consent of the participant.
Key exclusion criteria (2 listed)
- History of any ophthalmic surgery or ocular diseases (e.g., glaucoma, retinal disorders).
- Systemic diseases that affect vision or eye health (e.g., diabetes). After discontinuing RLRL treatment, other myopia control interventions other than monocular glasses should be employed (including atropine, orthokeratology lenses, defocused/DOT lenses, etc.).
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 |
|---|---|---|
| Repeated low-level red light (RLRL) therapyRepeated low-level red light (RLRL) therapy is an emerging treatment modality for myopia control. The participants were randomly assigned to three groups: the continued RLRL treatment group (RLRL-C), the discontinued RLRL treatment group (RLRL-I), and the gradually reduced RLRL treatment group (RLRL-T). | Device | the continued RLRL treatment group(RLRL-C), the discontinued RLRL treatment group (RLRL-I), the gradually reduced RLRL treatment group (RLRL-T) |
Primary outcome
Axial length(AL)
Time frame: Baseline, 6 months and12 months.
Change from baseline in Axial length [Unit of Measure:mm]
4 secondary outcomes
Change in Spherical Equivalent Refraction (SER)
Time frame: Baseline, 6 Months, 12 Months
Best-Corrected Visual Acuity (BCVA)
Time frame: Baseline, 6 Months, 12 Months
corneal curvature
Time frame: Baseline, 6 Months, 12 Months
Anterior Chamber Depth (ACD)
Time frame: Baseline,6 months and 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 5 Aug 2026.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated low-level red light (RLRL) therapy in people with Myopia and Randomized Controlled Trial (RCT), run by The First Affiliated Hospital of Anhui Medical University.
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 2 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: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Lixia Feng, Doctor (+8613075590585, lixiafeng75@fy.ahmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length(AL) (time frame: Baseline, 6 months and12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.