MyopiaNCT05203432
Red Light Intervention on Myopic Progression
A study testing Red Light Intervention and Atropine in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
To explore the effectiveness of using repeated low-level red-light therapy to slow myopia progression. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- Red Light Intervention and Atropine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2022to 30 Jun 2024
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age at enrolment: 6-12 years;
- At least one eye with spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D), and stigmatism of 1.50 D or less;
- Anisometropia of 1.5 D or less;
- The BCVA of distant vision is at least 0.8;
- Myopia progressed more than 0.5D in the past year;
- Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required;
- Written informed consent of guardian and child.
Who cannot join
- Strabismus, amblyopia or other ocular abnormalities;
- Other systemic abnormalities;
- Prior treatment of myopia control in 6 months, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye;
- Atropine allergy;
- Other situations that not suitable for participating in the trial as judged by the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, 201103
Xiangui He, +862153555032, hxgcrco@shsyf.com
About this study
Official title: The Effect and Safety of Red Light Intervention on Myopic Progression of Myopic Children: Randomized Clinical Trial
To explore the effectiveness of using repeated low-level red-light therapy to slow myopia progression.
- Conditions
- Myopia
- Being tested
- Red Light Intervention, Atropine
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Light InterventionDevice
Repeated Low-Level Red-Light Therapy
AtropineDrug
0.01% atropine
| Study group | Role | What they receive |
|---|---|---|
| Red Light Intervention | Experimental | Repeated Low-Level Red-Light Therapy Receives: Device: Red Light Intervention |
| Low concentration atropine | Active comparator | 0.01% atropine Receives: Drug: Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of axial length
AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster
Measured: at least 1 year
Secondary outcomes (3)
Change of spherical equivalent
Spherical equivalent as measured by cycloplegia autorefraction
Measured: at least 1 year
Change of choroidal thickness
Choroidal thickness will be measured using SS-OCT
Measured: at least 1 year
Change of uncorrected visual acuity
Uncorrected visual acuity (UCVA) will be measured using a mounted and illuminated E chart of the Early Treatment Diabetic Retinopathy study (ETDRS) charts.
Measured: at least 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start10 Feb 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (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
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiannan Huang, Principal investigator, Shanghai Eye Disease Prevention and Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203432
- Sponsor's protocol ID
- 21Y11910000
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Safety of Red Light Intervention on Myopic Progression of Myopic Children: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05203432
- Acronym / sponsor ID
- 21Y11910000
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 24 Jan 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.
To explore the effectiveness of using repeated low-level red-light therapy to slow myopia progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red Light Intervention | Experimental | Device: Red Light InterventionRepeated Low-Level Red-Light Therapy |
| Low concentration atropine | Active comparator | Drug: Atropine0.01% atropine |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age at enrolment: 6-12 years;
- At least one eye with spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D), and stigmatism of 1.50 D or less;
- Anisometropia of 1.5 D or less;
- The BCVA of distant vision is at least 0.8;
- Myopia progressed more than 0.5D in the past year;
Key exclusion criteria (5 listed)
- Strabismus, amblyopia or other ocular abnormalities;
- Other systemic abnormalities;
- Prior treatment of myopia control in 6 months, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye;
- Atropine allergy;
- Other situations that not suitable for participating in the trial as judged by the researcher.
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 |
|---|---|---|
| Red Light InterventionRepeated Low-Level Red-Light Therapy | Device | Red Light Intervention |
| Atropine0.01% atropine | Drug | Low concentration atropine |
Primary outcome
Changes of axial length
Time frame: at least 1 year
AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster
3 secondary outcomes
Change of spherical equivalent
Time frame: at least 1 year
Change of choroidal thickness
Time frame: at least 1 year
Change of uncorrected visual acuity
Time frame: at least 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
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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.
Jiannan Huang principal investigator
Shanghai Eye Disease Prevention and Treatment Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Light Intervention and Atropine in people with Myopia, 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 7 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: status not confirmed, as of the sponsor's last update on 12 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiannan Huang (+8602153555032, miller23@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of axial length (time frame: at least 1 year). 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 12 Oct 2022; AzTrials last refreshed its copy on 27 Oct 2026.