MyopiaNCT04073238
Efficacy of Repeated Low-Level Red-Light Therapy in Myopia Control
A study testing Low-level Red-light Therapy in people with Myopia and Refractive Errors, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 4 sites in China.
Trial summary
The purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in Chinese schoolchildren. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Myopia, Refractive Errors, Eye Diseases
- What is being tested?
- Low-level Red-light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 4 sitesChina
- Study dates
- 23 Jul 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age at enrolment: 8-13 years
- Spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D)
- Astigmatism of 2.50 D or less
- Anisometropia of 1.5 D or less
- Spectacle corrected monocular logMAR visual acuity (VA): 0 or better
- Parents' understanding and acceptance of random allocation of grouping
Who cannot join
- Strabismus and binocular vision abnormalities in either eye
- Ocular abnormalities in either eye or other systemic abnormalities
- Prior treatment of myopia control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye
- Other contraindications in either eye
Trial locations and contacts
4 sites in 1 country.
China4 sites
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
The Second People's Hospital of Foshan
Foshan, Guangdong, 528000
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Shenzhen Children's Hospital
Shenzhen, Guangdong, 518038
About this study
Official title: The Clinical Trial of Myopia Control in Schoolchildren Using the Repeated Low-Level Red-Light Therapy
The purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in Chinese schoolchildren.
Read the detailed description
Low level light therapy (LLLT) is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. Its potential mechanisms of improving choroidal metabolic rate and circulation may improve scleral hypoxia, thus slowing down the progression of myopia. The investigator's preliminary case-series study suggested that repeated low-level red-light therapy was effective in slowing myopia progression without any clinically observable side effects. Using a randomized clinical trial design, the purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in Chinese schoolchildren. Study subjects will be randomly assigned to either the treatment group (receive repeated low-level red-light therapy) or the control group (wearing ordinary single vision lenses). Axial length and cycloplegic refraction will be monitored over one year (1st month, 3rd month, 6th month and 12th month), after which changes in axial length and refractive errors in the two groups will be compared. An interim analysis will be performed at the 3rd month, at which the data will be reported and presented. Appropriate adjustment of the p-value and decision on the continuation of the study will be made.
- Conditions
- Myopia, Refractive Errors, Eye Diseases
- Being tested
- Low-level Red-light Therapy
- Medical subject headings
- Myopia, Refractive Errors, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level Red-light TherapyDevice
In addition to wearing single vision spectacle lens with power for correcting distance refraction, low-level red-light therapy is performed twice per school day at home with an interval of at least 4 hours, each treatment lasting 3 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Single vision spectacle lens | No intervention | Single vision lens with power for correcting distance refraction. |
| Repeated low-level red-light therapy | Experimental | Single vision lens \& repeated low-level red-light therapy Receives: Device: Low-level Red-light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length change (mm)
Axial length change (mm) is characterized as the difference between each follow-up visit and baseline values. The IOLMaster is used to measure axial length (mm).
Measured: 1 month, 3 months, 6 months and 1 year
Secondary outcomes (9)
Cycloplegic spherical equivalent change (Diopter)
Cycloplegic spherical equivalent change (Diopter, D) is characterized as the difference between each follow-up visit and baseline values. Cycloplegia is induced with one drop of Alcaine 0.5% followed by two drops of 1% cyclopentolate administered at 0, 5th to each eye. The third drop of cyclopentolate is used if the light reflex exists after 20 minute. The light reflex and pupil dilation is checked after an additional 15 minutes. Dilation and light reflex status is recorded and full cycloplegia is justified if the pupil dilates to 6 millimeters or greater and the light reflex is absent. Refraction is performed with an auto-refractor. The data on spherical and cylindrical power and axis is automatically extracted from the auto-refractor. The spherical equivalent power (D) is calculated as the spherical power (D) plus half of the cylindrical power (D).
Measured: 1 month, 3 months, 6 months and 1 year
Corneal curvature change (mm)
Corneal curvature (mm) is characterized as the difference between each follow-up visit and baseline values. The IOLMaster is used to measure corneal curvature (mm).
Measured: 1 month, 3 months, 6 months and 1 year
Anterior chamber depth change (mm)
Anterior chamber depth (mm) is characterized as the difference between each follow-up visit and baseline values. The IOLMaster is used to measure anterior chamber depth (mm).
Measured: 1 month, 3 months, 6 months and 1 year
White to white change (mm)
White to white (mm) is characterized as the difference between each follow-up visit and baseline values. The IOLMaster is used to measure white to white (mm).
Measured: 1 month, 3 months, 6 months and 1 year
Visual acuity change
Visual acuity change is characterized as the difference between each follow-up visit and baseline values. An ETDRS chart (Precision vision, Villa Park, Illinois, USA) with standard illumination is used to measure distance visual acuity. Visual acuity measurement is performed at a distance of 4 meters. Uncorrected visual acuity is measured for all children.
Measured: 1 month, 3 months, 6 months and 1 year
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over a specified period for subjects in the intervention arm. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.
Measured: 1 month
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over a specified period for subjects in the intervention arm. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.
Measured: 3 months
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over a specified period for subjects in the intervention arm. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.
Measured: 6 months
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over a specified period for subjects in the intervention arm. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start23 Jul 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Children's Hospital, The Second People's Hospital of Foshan, Xiangya Hospital of Central South University
- Responsible party
- Sponsor
- Investigators
- Mingguang He, Professor, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073238
- Sponsor's protocol ID
- 2019KYPJ093
- Status last verified
- Jan 2022
- First submitted
- 18 Aug 2019
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wang W, Jiang Y, Zhu Z, Zhang S, Xuan M, Tan X, Kong X, Zhong H, Bulloch G, Xiong R, Yuan Y, Chen Y, Zhang J, Zeng J, Morgan IG, He M. Axial Shortening in Myopic Children after Repeated Low-Level Red-Light Therapy: Post Hoc Analysis of a Randomized Trial. Ophthalmol Ther. 2023 Apr;12(2):1223-1237. doi: 10.1007/s40123-023-00671-7. Epub 2023 Feb 15.
PubMed 36790672Xiong R, Zhu Z, Jiang Y, Wang W, Zhang J, Chen Y, Bulloch G, Yuan Y, Zhang S, Xuan M, Zeng J, He M. Longitudinal Changes and Predictive Value of Choroidal Thickness for Myopia Control after Repeated Low-Level Red-Light Therapy. Ophthalmology. 2023 Mar;130(3):286-296. doi: 10.1016/j.ophtha.2022.10.002. Epub 2022 Oct 11.
PubMed 36240954
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Trial of Myopia Control in Schoolchildren Using the Repeated Low-Level Red-Light Therapy
- ClinicalTrials.gov ID
- NCT04073238
- Acronym / sponsor ID
- 2019KYPJ093
- Conditions
- Myopia, Refractive Errors, Eye Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Children's Hospital, The Second People's Hospital of Foshan, Xiangya Hospital of Central South University
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Aug 2019 (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 study is to determine if repeated low-level red-light therapy can slow myopia progression in Chinese schoolchildren.
Detailed description
Low level light therapy (LLLT) is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. Its potential mechanisms of improving choroidal metabolic rate and circulation may improve scleral hypoxia, thus slowing down the progression of myopia. The investigator's preliminary case-series study suggested that repeated low-level red-light therapy was effective in slowing myopia progression without any clinically observable side effects. Using a randomized clinical trial design, the purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in Chinese schoolchildren. Study subjects will be randomly assigned to either the treatment group (receive repeated low-level red-light therapy) or the control group (wearing ordinary single vision lenses). Axial length and cycloplegic refraction will be monitored over one year (1st month, 3rd month, 6th month and 12th month), after which changes in axial length and refractive errors in the two groups will be compared. An interim analysis will be performed at the 3rd month, at which the data will be reported and presented. Appropriate adjustment of the p-value and decision on the continuation of the study will be made.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single vision spectacle lens | No intervention | –Single vision lens with power for correcting distance refraction. |
| Repeated low-level red-light therapy | Experimental | Device: Low-level Red-light TherapySingle vision lens \& repeated low-level red-light therapy |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age at enrolment: 8-13 years
- Spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D)
- Astigmatism of 2.50 D or less
- Anisometropia of 1.5 D or less
- Spectacle corrected monocular logMAR visual acuity (VA): 0 or better
Key exclusion criteria (4 listed)
- Strabismus and binocular vision abnormalities in either eye
- Ocular abnormalities in either eye or other systemic abnormalities
- Prior treatment of myopia control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye
- Other contraindications in either eye
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 |
|---|---|---|
| Low-level Red-light TherapyIn addition to wearing single vision spectacle lens with power for correcting distance refraction, low-level red-light therapy is performed twice per school day at home with an interval of at least 4 hours, each treatment lasting 3 minutes. | Device | Repeated low-level red-light therapy |
Primary outcome
Axial length change (mm)
Time frame: 1 month, 3 months, 6 months and 1 year
Axial length change (mm) is characterized as the difference between each follow-up visit and baseline values. The IOLMaster is used to measure axial length (mm).
9 secondary outcomes
Cycloplegic spherical equivalent change (Diopter)
Time frame: 1 month, 3 months, 6 months and 1 year
Corneal curvature change (mm)
Time frame: 1 month, 3 months, 6 months and 1 year
Anterior chamber depth change (mm)
Time frame: 1 month, 3 months, 6 months and 1 year
White to white change (mm)
Time frame: 1 month, 3 months, 6 months and 1 year
Visual acuity change
Time frame: 1 month, 3 months, 6 months and 1 year
Incidence of treatment-emergent adverse events
Time frame: 1 month
Incidence of treatment-emergent adverse events
Time frame: 3 months
Incidence of treatment-emergent adverse events
Time frame: 6 months
Incidence of treatment-emergent adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Derived from this study: PubMed 36790672Wang W, Jiang Y, Zhu Z, Zhang S, Xuan M, Tan X, Kong X, Zhong H, Bulloch G, Xiong R, Yuan Y, Chen Y, Zhang J, Zeng J, Morgan IG, He M. Axial Shortening in Myopic Children after Repeated Low-Level Red-Light Therapy: Post Hoc Analysis of a Randomized Trial. Ophthalmol Ther. 2023 Apr;12(2):1223-1237. doi: 10.1007/s40123-023-00671-7. Epub 2023 Feb 15.
- Derived from this study: PubMed 36240954Xiong R, Zhu Z, Jiang Y, Wang W, Zhang J, Chen Y, Bulloch G, Yuan Y, Zhang S, Xuan M, Zeng J, He M. Longitudinal Changes and Predictive Value of Choroidal Thickness for Myopia Control after Repeated Low-Level Red-Light Therapy. Ophthalmology. 2023 Mar;130(3):286-296. doi: 10.1016/j.ophtha.2022.10.002. Epub 2022 Oct 11.
- 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. This study is not recruiting at the moment.
Mingguang He, Professor principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level Red-light Therapy in people with Myopia and Refractive Errors, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 4 sites 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 4 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: status not confirmed, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
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?
Axial length change (mm) (time frame: 1 month, 3 months, 6 months and 1 year). 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 NCT04073238, which also lists 2 linked publications.
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 6 Jan 2022.