High MyopiaNCT05550740
Repeated Low-Level Red-Light Therapy for Shortening Axial Length
A study testing RLRL in people with High Myopia and Refractive Errors, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
The purpose of this clinical trial is to confirm the incidence and magnitude of axial length shortening after RLRL therapy in Chinese high myopia children and teenagers. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- High Myopia, Refractive Errors, Eye Diseases
- What is being tested?
- RLRL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2022to 23 Mar 2026
- 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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Provision of consent.
- Age: ≥ 6 and ≤ 16 years at enrolment.
- High myopia: cycloplegic sphere ≤ -6.00 diopters (D) in both eyes.
- Willing and able to participate in all required activities of the study.
- The children currently on myopia control treatment can be recruited if myopia control treatments (including but not limited to atropine, orthokeratology, rigid gas-permeable lenses, defocus spectacles, etc.) are discontinued for at least 2 weeks.
- Normal fundus, tessellated fundus or with peripapillary diffuse chorioretinal atrophy.
Who cannot join
- Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
- Pathologic myopia with signs of macula-involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or Fuchs' spots.
- Strabismus and binocular vision abnormalities in either eye.
- Previous any intraocular surgery affecting refractive status.
- Other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, 20041
About this study
Official title: Repeated Low-Level Red-Light Therapy for Shortening Axial Length in Chinese High Myopia Children and Teenagers: a Prospective Single-Arm Study
The purpose of this clinical trial is to confirm the incidence and magnitude of axial length shortening after RLRL therapy in Chinese high myopia children and teenagers.
Read the detailed description
High myopia has become a major public concern globally, which is characterized by excessive axial elongation of the eyeball. Axial elongation is accompanied by mechanical stretching and thinning of the choroid and sclera, causing vision-threatening complications. RLRL therapy is an emerging effective and safe therapy for myopia control. Previous clinical trials in China have observed clinically significant axial shortening after RLRL treatment.
The purpose of this study is to confirm and identify possible mechanism for axial length (AL) shortening after 12-month RLRL therapy in Chinese highly myopic children and teenagers aged 6-16 years. In addition to single vision spectacles, subjects will receive RLRL treatment at home under supervision of the parents according to a standard protocol. Axial length, visual acuity, cycloplegic spherical equivalent refraction, intraocular pressure, slit lamp, optical coherence tomography, optical coherence tomography angiography and ultrawide-field optical coherence tomography will be measured at 1-, 3-, 6- and 12-month follow-up visits. This trial will be extended to 3 years and follow-up visits are scheduled at 18-, 24-, 30- and 36-month.
- Conditions
- High Myopia, Refractive Errors, Eye Diseases
- Being tested
- RLRL
- Medical subject headings
- Refractive Errors, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLRLDevice
In addition to SVS with power for correcting distance refraction, RLRL will be performed twice per school day with an interval of at least 4 hours, each treatment last 3 minutes.
| Study group | Role | What they receive |
|---|---|---|
| RLRL therapy | Experimental | In addition to SVS, participants will be treated with RLRL twice a school day. Receives: Device: RLRL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate (%) of axial length shortening >0.05 mm measured by the IOL Master
Incidence rate of axial length shortening > 0.05 mm is characterized as the ratio of number of participants with axial length shortening greater than 0.05 mm to the total number.
Measured: 12 months
Secondary outcomes (9)
Incidence rates (%) of axial length shortening >0.10 mm and >0.20 mm measured by the IOL Master
Incidence rate of axial length shortening > 0.10 mm and 0.20 mm are characterized as the ratio of number of participants with axial length hortening greater than 0.10 mm and 0.20 mm to the total number.
Measured: 12 months
Changes of axial length shortening (mm) among shortened eyes measured the IOL master
Changes of axial length shortening is characterized as the magnitude of axial length reduction among axial shortened eyes.
Measured: 12 months
Changes in choroidal structural and perfusion parameters measured by the swept-source optical coherence tomography and optical coherence tomography angiography
Changes in choroidal structural and perfusion parameters are characterized as the difference between each follow-up visit and corresponding baseline values. Indicators include choroidal vascular index, choroidal thickness and so on.
Measured: 1, 3, 6 and 12 months
Changes in retinal structures by the swept-source optical coherence tomography and optical coherence tomography angiography
Swept-source optical coherence tomography is used to measure retinal structures. The structures of nerve sensory layer, retinal pigment epithelium layer and choroid layer were observed by fundus images.
Measured: 1, 3, 6 and 12 months
Changes in axial length (mm) and other biometric parameters (mm, μm) by the IOL master
The IOL Master is used to measure axial length and other biometric parameters, including corneal curvature, anterior chamber depth and white to white, etc. Change of each parameter is characterized as the difference between each follow-up visit and baseline values
Measured: 1, 3, 6 and 12 months
Change of cycloplegic spherical equivalent refraction (Diopter) by the autorefractor
Cycloplegic spherical equivalent change (Diopter, D) is characterized as the difference between each follow-up visit and baseline values. Refraction with full cycloplegia is performed with an autorefractor. The data on spherical and cylindrical power and axis is automatically extracted from the autorefractor. The spherical equivalent power (D) is calculated as the spherical power (D) plus half of the cylindrical power (D)
Measured: 1, 3, 6 and 12 months
Change of pathologic myopia fundus META-PM grading
The swept-source optical coherence tomography is used to obtain fundus images. The fundus images are classified based on META-PM classification system
Measured: 1, 3, 6 and 12 months
Change in best corrected visual acuity (logMAR) by the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart
Best corrected visual acuity change is characterized as the difference between each follow-up visit and baseline values. An Early Treatment Diabetic Retinopathy Study chart with standard illumination at a distance of 4 meters is used to measure best corrected visual acuity
Measured: 1, 3, 6, and 12 months
Incidence (%) of self-reported adverse events by the quesionnaire including but not limited to glare, flash blindness, and afterimages
Incidence of self-reported adverse events is the rate of self-reported adverse events over a specified period for all the subjects.
Measured: 1, 3, 6 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 posted22 Sep 2022
- Study start19 Nov 2022
- Primary completion1 Mar 2026 (estimated)
- Study completion23 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550740
- Sponsor's protocol ID
- HMRL-SEPTC-2022
- Status last verified
- Nov 2024
- First submitted
- 20 Sep 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared as open data after proper anonymization.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Low-Level Red-Light Therapy for Shortening Axial Length in Chinese High Myopia Children and Teenagers: a Prospective Single-Arm Study
- ClinicalTrials.gov ID
- NCT05550740
- Acronym / sponsor ID
- HMRL-SEPTC-2022
- Conditions
- High Myopia, Refractive Errors, Eye Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 19 Nov 2022 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 23 Mar 2026 (estimated)
- First posted
- 22 Sep 2022 (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.
The purpose of this clinical trial is to confirm the incidence and magnitude of axial length shortening after RLRL therapy in Chinese high myopia children and teenagers.
Detailed description
High myopia has become a major public concern globally, which is characterized by excessive axial elongation of the eyeball. Axial elongation is accompanied by mechanical stretching and thinning of the choroid and sclera, causing vision-threatening complications. RLRL therapy is an emerging effective and safe therapy for myopia control. Previous clinical trials in China have observed clinically significant axial shortening after RLRL treatment.
The purpose of this study is to confirm and identify possible mechanism for axial length (AL) shortening after 12-month RLRL therapy in Chinese highly myopic children and teenagers aged 6-16 years. In addition to single vision spectacles, subjects will receive RLRL treatment at home under supervision of the parents according to a standard protocol. Axial length, visual acuity, cycloplegic spherical equivalent refraction, intraocular pressure, slit lamp, optical coherence tomography, optical coherence tomography angiography and ultrawide-field optical coherence tomography will be measured at 1-, 3-, 6- and 12-month follow-up visits. This trial will be extended to 3 years and follow-up visits are scheduled at 18-, 24-, 30- and 36-month.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RLRL therapy | Experimental | Device: RLRLIn addition to SVS, participants will be treated with RLRL twice a school day. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Provision of consent.
- Age: ≥ 6 and ≤ 16 years at enrolment.
- High myopia: cycloplegic sphere ≤ -6.00 diopters (D) in both eyes.
- Willing and able to participate in all required activities of the study.
- The children currently on myopia control treatment can be recruited if myopia control treatments (including but not limited to atropine, orthokeratology, rigid gas-permeable lenses, defocus spectacles, etc.) are discontinued for at least 2 weeks.
Key exclusion criteria (5 listed)
- Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
- Pathologic myopia with signs of macula-involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or Fuchs' spots.
- Strabismus and binocular vision abnormalities in either eye.
- Previous any intraocular surgery affecting refractive status.
- Other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.
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 |
|---|---|---|
| RLRLIn addition to SVS with power for correcting distance refraction, RLRL will be performed twice per school day with an interval of at least 4 hours, each treatment last 3 minutes. | Device | RLRL therapy |
Primary outcome
Incidence rate (%) of axial length shortening >0.05 mm measured by the IOL Master
Time frame: 12 months
Incidence rate of axial length shortening > 0.05 mm is characterized as the ratio of number of participants with axial length shortening greater than 0.05 mm to the total number.
9 secondary outcomes
Incidence rates (%) of axial length shortening >0.10 mm and >0.20 mm measured by the IOL Master
Time frame: 12 months
Changes of axial length shortening (mm) among shortened eyes measured the IOL master
Time frame: 12 months
Changes in choroidal structural and perfusion parameters measured by the swept-source optical coherence tomography and optical coherence tomography angiography
Time frame: 1, 3, 6 and 12 months
Changes in retinal structures by the swept-source optical coherence tomography and optical coherence tomography angiography
Time frame: 1, 3, 6 and 12 months
Changes in axial length (mm) and other biometric parameters (mm, μm) by the IOL master
Time frame: 1, 3, 6 and 12 months
Change of cycloplegic spherical equivalent refraction (Diopter) by the autorefractor
Time frame: 1, 3, 6 and 12 months
Change of pathologic myopia fundus META-PM grading
Time frame: 1, 3, 6 and 12 months
Change in best corrected visual acuity (logMAR) by the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart
Time frame: 1, 3, 6, and 12 months
Incidence (%) of self-reported adverse events by the quesionnaire including but not limited to glare, flash blindness, and afterimages
Time frame: 1, 3, 6 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 30 Mar 2025.
- Individual participant dataSharing planned: Yes. Data will be shared as open data after proper anonymization.
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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 RLRL in people with High Myopia and Refractive Errors, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
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 6 inclusion and 5 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 30 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 China. 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?
Incidence rate (%) of axial length shortening >0.05 mm measured by the IOL Master (time frame: 12 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 30 Mar 2025.