Age 3 to 16 Years (Inclusive), Male or FemaleNCT05184621
The Effectiveness and Safety of Low-intensity Single-wavelength Red Light in Controlling High Myopia in Children and Adolescents：A Randomized, Controlled, Multicenter Clinical Trial
A study testing Eyesing Redlight Instrument in people with Age 3 to 16 Years (Inclusive), Male or Female and Clinical Diagnosis Confirming That Myopia Has Occurred in at Least One Eye, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
Objective: To study the effectiveness and safety of low-intensity single wavelength red light in controlling high myopia in children and adolescents. Methods: Subject population: Children aged 3-16 years who have high myopia. Read more about this study
- Who is it for?
- Ages 3 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Age 3 to 16 Years (Inclusive), Male or Female, Clinical Diagnosis Confirming That Myopia Has Occurred in at Least One Eye, The Guardian Voluntarily Signed the Subject's Informed Consent Form
- What is being tested?
- Eyesing Redlight Instrument
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2021to 15 Apr 2023
- 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 3 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 3 to 16 years (inclusive), male or female
- clinical diagnosis confirming that myopia has occurred in at least one eye.
- the guardian voluntarily signed the "Subject's Informed Consent Form"
Who cannot join
- history of photosensitivity, glaucoma, glaucoma syndrome, high intraocular pressure, macular lesion or injury in the fundus ② corneal curvature examination, the average K value of the anterior surface of the cornea ≥ 45; ③ combined with heart, liver, kidney and other systemic diseases and prior.
- Combination of cardiac, hepatic, renal, and other systemic diseases and congenital myopia; ④ Combination of ocular trauma and congenital myopia.
- ④ Combined with ocular trauma and chronic ocular diseases such as apparently oblique or operated eyes, atopic keratoconjunctivitis, etc.; ⑤ Previous presence of entropion.
- ⑤ Those with previous entropion and other eye diseases such as severe corneal and conjunctival infections; ⑥ Those with combined neurological diseases and other eye diseases.
- Those with combined neurological disorders and allergies or contraindications to atropine drugs or other therapeutic drugs; (7) Albinism and psoriasis.
- Patients with albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, diabetes mellitus, and other immune system and systemic diseases; (8) Epilepsy, psychiatric disorders.
Show all 10Show fewer
- ⑧ epilepsy, mental disorders who cannot communicate normally.
- Previously treated with other treatments to control the development of myopia such as anticholinergic drugs such as atropine within 3 months, or involved in other functional
- Previously treated with other treatments to control the development of myopia, such as anticholinergic drugs like atropine within 3 months, or involved in other studies related to functional frame lenses, multifocal soft lenses, etc.
- Other conditions judged by the investigator to be unsuitable for participation in the study
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, 200040
About this study
Objective: To study the effectiveness and safety of low-intensity single wavelength red light in controlling high myopia in children and adolescents.
Methods: Subject population: Children aged 3-16 years who have high myopia. Sample size: 190 subjects were planned to be enrolled and assigned to the test or control group in a 1:1 ratio.
Read the detailed description
Design: The trial was a randomized, controlled, multicenter clinical trial. A total of 190 children aged 3-16 years with high myopia were selected and divided into 95 cases in the test group and 95 cases in the control group. The test group was treated with the Eyesing Instrument developed by Suzhou Industrial Park Zoguan Medical Equipment Co. and conventional optometry. The safety and efficacy of the low-energy laser device in the test group were evaluated by comparing the changes in myopia between the two groups during the observation period. Subjects were screened after signing the informed consent form (performed as early as 7 days before the randomization), and the examination used for screening could use the results of eye examinations performed within 1 week at our hospital, and they were enrolled after confirming that they met the inclusion criteria. On the same day, the grouping was done by randomization, and the glasses were prescribed or the glasses were prescribed in combination with the device according to the grouping results. Visits were performed at 30± 14 days, 90± 14 days, 180± 14 days, 270± 14 days, and 365± 14 days
- Conditions
- Age 3 to 16 Years (Inclusive), Male or Female, Clinical Diagnosis Confirming That Myopia Has Occurred in at Least One Eye, The Guardian Voluntarily Signed the Subject's Informed Consent Form
- Being tested
- Eyesing Redlight Instrument
- Keywords
- high myopia, red light, children and adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyesing Redlight InstrumentOther
Eyesing Instrument developed by Suzhou Industrial Park Zoguan Medical Equipment Co. and conventional optometry.
| Study group | Role | What they receive |
|---|---|---|
| efficacy | Active comparator | Including Primary outcome: changes in axial length of the eye. Secondary outcome: Equivalent spherical lens variation Other indicators: ① Changes in visual acuity with lenses, corrected visual acuity, and intraocular pressure.② Observation of changes in corneal thickness, anterior chamber depth, ciliary body thickness, and crystal thickness.Observation of fundus tissue structure of macula and peri-optic disc area. Observation of fundus choroidal/retinal thickness.Adherence index: frequency of device use. Receives: Other: Eyesing Redlight Instrument |
| safety | Active comparator | Description of safety parameters: Adverse events, device defects during the test.
Method and time selection for evaluation, recording, and analysis of safety parameters. Adverse events and device defects were recorded from the beginning of each subject's enrollment to the end of the group for evaluation. Safety indicators:① Incidence of allergic reactions.② Posterior image time more than 5 minutes.③ The decrease of near vision.④ The grade of side effects such as self-induced photophobia and blurred vision.⑤ Elevated intraocular pressure, headache, nausea, and vomiting, etc. Receives: Other: Eyesing Redlight Instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length changes
Axial length changes in the left and right eyes
Measured: 30± 14 days, 90± 14 days, 180± 14 days, 270± 14 days, and 365± 14 days
Secondary outcomes (1)
change in equivalent spherical
change in equivalent spherical in both eyes
Measured: day 365±14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start4 Feb 2021
- Primary completion15 Apr 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Age 3 to 16 Years (Inclusive), Male or FemaleStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Main efficacy indicators. Axial length changes in the left and right eyes (30± 14 days, 90± 14 days, 180± 14 days, 270± 14 days, and 365± 14 days).Secondary efficacy indicator: change in equivalent spherical lens after astigmatism (day 365±14)
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Collaborators
- Zuoguan Medical Equipment Co., Ltd. at Suzhou Industrial Park, Children's Hospital of Soochow University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai East Hospital, The Children's Hospital of Zhejiang University School of Medicine, Shanxi Eye Hospital
- Responsible party
- Principal investigator, XuYan, Shanghai Eye Disease Prevention and Treatment Center
- Investigators
- Haidong Zou, advanced, Principal investigator, Shanghai Genral Hospital/Shanghai Eye disease Treatment&Prevention Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184621
- Sponsor's protocol ID
- ShanghaiEye
- Status last verified
- Nov 2023
- First submitted
- 22 Dec 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He M, Zeng J, Liu Y, Xu J, Pokharel GP, Ellwein LB. Refractive error and visual impairment in urban children in southern china. Invest Ophthalmol Vis Sci. 2004 Mar;45(3):793-9. doi: 10.1167/iovs.03-1051.
PubMed 14985292Zhao J, Pan X, Sui R, Munoz SR, Sperduto RD, Ellwein LB. Refractive Error Study in Children: results from Shunyi District, China. Am J Ophthalmol. 2000 Apr;129(4):427-35. doi: 10.1016/s0002-9394(99)00452-3.
PubMed 10764849Maul E, Barroso S, Munoz SR, Sperduto RD, Ellwein LB. Refractive Error Study in Children: results from La Florida, Chile. Am J Ophthalmol. 2000 Apr;129(4):445-54. doi: 10.1016/s0002-9394(99)00454-7.
PubMed 10764851Pokharel GP, Negrel AD, Munoz SR, Ellwein LB. Refractive Error Study in Children: results from Mechi Zone, Nepal. Am J Ophthalmol. 2000 Apr;129(4):436-44. doi: 10.1016/s0002-9394(99)00453-5.
PubMed 10764850Xu Y, Cui L, Kong M, Li Q, Feng X, Feng K, Zhu H, Cui H, Shi C, Zhang J, Zou H. Repeated Low-Level Red Light Therapy for Myopia Control in High Myopia Children and Adolescents: A Randomized Clinical Trial. Ophthalmology. 2024 Nov;131(11):1314-1323. doi: 10.1016/j.ophtha.2024.05.023. Epub 2024 Jun 6.
PubMed 38849054
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Low-intensity Single-wavelength Red Light in Controlling High Myopia in Children and Adolescents：A Randomized, Controlled, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT05184621
- Acronym / sponsor ID
- ShanghaiEye
- Conditions
- Age 3 to 16 Years (Inclusive), Male or Female, Clinical Diagnosis Confirming That Myopia Has Occurred in at Least One Eye, The Guardian Voluntarily Signed the Subject's Informed Consent Form
- Keywords
- high myopia, red light, children and adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Collaborators
- Zuoguan Medical Equipment Co., Ltd. at Suzhou Industrial Park, Children's Hospital of Soochow University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai East Hospital, The Children's Hospital of Zhejiang University School of Medicine, Shanxi Eye Hospital
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 11 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.
Objective: To study the effectiveness and safety of low-intensity single wavelength red light in controlling high myopia in children and adolescents.
Methods: Subject population: Children aged 3-16 years who have high myopia. Sample size: 190 subjects were planned to be enrolled and assigned to the test or control group in a 1:1 ratio.
Detailed description
Design: The trial was a randomized, controlled, multicenter clinical trial. A total of 190 children aged 3-16 years with high myopia were selected and divided into 95 cases in the test group and 95 cases in the control group. The test group was treated with the Eyesing Instrument developed by Suzhou Industrial Park Zoguan Medical Equipment Co. and conventional optometry. The safety and efficacy of the low-energy laser device in the test group were evaluated by comparing the changes in myopia between the two groups during the observation period. Subjects were screened after signing the informed consent form (performed as early as 7 days before the randomization), and the examination used for screening could use the results of eye examinations performed within 1 week at our hospital, and they were enrolled after confirming that they met the inclusion criteria. On the same day, the grouping was done by randomization, and the glasses were prescribed or the glasses were prescribed in combination with the device according to the grouping results. Visits were performed at 30± 14 days, 90± 14 days, 180± 14 days, 270± 14 days, and 365± 14 days
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Main efficacy indicators. Axial length changes in the left and right eyes (30± 14 days, 90± 14 days, 180± 14 days, 270± 14 days, and 365± 14 days).Secondary efficacy indicator: change in equivalent spherical lens after astigmatism (day 365±14)
| Arm | Type | Receives |
|---|---|---|
| efficacy | Active comparator | Other: Eyesing Redlight InstrumentIncluding Primary outcome: changes in axial length of the eye. Secondary outcome: Equivalent spherical lens variation Other indicators: ① Changes in visual acuity with lenses, corrected visual acuity, and intraocular pressure.② Observation of changes in corneal thickness, anterior chamber depth, ciliary body thickness, and crystal thickness.Observation of fundus tissue structure of macula and peri-optic disc area. Observation of fundus choroidal/retinal thickness.Adherence index: frequency of device use. |
| safety | Active comparator | Other: Eyesing Redlight InstrumentDescription of safety parameters: Adverse events, device defects during the test. Method and time selection for evaluation, recording, and analysis of safety parameters. Adverse events and device defects were recorded from the beginning of each subject's enrollment to the end of the group for evaluation. Safety indicators:① Incidence of allergic reactions.② Posterior image time more than 5 minutes.③ The decrease of near vision.④ The grade of side effects such as self-induced photophobia and blurred vision.⑤ Elevated intraocular pressure, headache, nausea, and vomiting, etc. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age 3 to 16 years (inclusive), male or female
- clinical diagnosis confirming that myopia has occurred in at least one eye.
- the guardian voluntarily signed the "Subject's Informed Consent Form"
Key exclusion criteria (10 listed)
- ④ Combined with ocular trauma and chronic ocular diseases such as apparently oblique or operated eyes, atopic keratoconjunctivitis, etc.; ⑤ Previous presence of entropion.
- ⑤ Those with previous entropion and other eye diseases such as severe corneal and conjunctival infections; ⑥ Those with combined neurological diseases and other eye diseases.
- ⑧ epilepsy, mental disorders who cannot communicate normally.
- Other conditions judged by the investigator to be unsuitable for participation in the study
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 |
|---|---|---|
| Eyesing Redlight InstrumentEyesing Instrument developed by Suzhou Industrial Park Zoguan Medical Equipment Co. and conventional optometry. | Other | efficacy, safety |
Primary outcome
Axial length changes
Time frame: 30± 14 days, 90± 14 days, 180± 14 days, 270± 14 days, and 365± 14 days
Axial length changes in the left and right eyes
1 secondary outcome
change in equivalent spherical
Time frame: day 365±14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Results publication: PubMed 14985292He M, Zeng J, Liu Y, Xu J, Pokharel GP, Ellwein LB. Refractive error and visual impairment in urban children in southern china. Invest Ophthalmol Vis Sci. 2004 Mar;45(3):793-9. doi: 10.1167/iovs.03-1051.
- Results publication: PubMed 10764849Zhao J, Pan X, Sui R, Munoz SR, Sperduto RD, Ellwein LB. Refractive Error Study in Children: results from Shunyi District, China. Am J Ophthalmol. 2000 Apr;129(4):427-35. doi: 10.1016/s0002-9394(99)00452-3.
- Results publication: PubMed 10764851Maul E, Barroso S, Munoz SR, Sperduto RD, Ellwein LB. Refractive Error Study in Children: results from La Florida, Chile. Am J Ophthalmol. 2000 Apr;129(4):445-54. doi: 10.1016/s0002-9394(99)00454-7.
- Results publication: PubMed 10764850Pokharel GP, Negrel AD, Munoz SR, Ellwein LB. Refractive Error Study in Children: results from Mechi Zone, Nepal. Am J Ophthalmol. 2000 Apr;129(4):436-44. doi: 10.1016/s0002-9394(99)00453-5.
- Derived from this study: PubMed 38849054Xu Y, Cui L, Kong M, Li Q, Feng X, Feng K, Zhu H, Cui H, Shi C, Zhang J, Zou H. Repeated Low-Level Red Light Therapy for Myopia Control in High Myopia Children and Adolescents: A Randomized Clinical Trial. Ophthalmology. 2024 Nov;131(11):1314-1323. doi: 10.1016/j.ophtha.2024.05.023. Epub 2024 Jun 6.
- Individual participant dataSharing planned: No
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.
Haidong Zou, advanced principal investigator
Shanghai Genral Hospital/Shanghai Eye disease Treatment&Prevention 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 Eyesing Redlight Instrument in people with Age 3 to 16 Years (Inclusive), Male or Female and Clinical Diagnosis Confirming That Myopia Has Occurred in at Least One Eye, 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 18 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 changes (time frame: 30± 14 days, 90± 14 days, 180± 14 days, 270± 14 days, and 365± 14 days). 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 NCT05184621, which also lists 5 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 18 Nov 2023.