High MyopiaNCT05947019
Efficacy and Safety of Low-Level Monochromatic Red-Light for High Myopia Control in Adults
A study testing Myopic amblyopia comprehensive treatment instrument and Glasses in people with High Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
The purpose of this clinical study is to confirm the effectiveness and safety of low-level monochromatic red-light for high myopia control in adults Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- High Myopia
- What is being tested?
- Myopic amblyopia comprehensive treatment instrument and Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Oct 2025
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 40 years, regardless of gender.
- Presence of myopic refractive error in at least one eye, with myopic lens power after mydriasis exceeding 6.00D, diffusivity less than 2.00D, binocular anisometropia less than 3.00D, and best corrected distance visual acuity of at least 0.6, as well as near visual acuity of at least 0.6.
- Normal cognitive abilities and language communication skills, capable of actively cooperating with the required treatment.
- Absence of contraindications for atropine use, such as acute ocular inflammation, dry eye, keratoconus, and diabetes.
- Written informed consent obtained from the patients.
Who cannot join
- History of photoallergy, glaucoma, trichiasis syndrome, ocular hypertension, fundus macula lesions, or eye injuries.
- Corneal curvature examination revealing an average K value of the anterior corneal surface of ≥45.
- Presence of systemic diseases (e.g., heart, liver, kidney diseases) and congenital hereditary myopia.
- Chronic eye diseases, including ocular trauma, strabismus, or previous ocular surgery, as well as allergic conjunctivitis.
- Previous internal trichiasis, severe corneal opacity, conjunctival infection, or other eye diseases.
- Neurological diseases, allergies, or contraindications to atropine or other therapeutic drugs.
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- Presence of immune system and systemic diseases such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, or diabetes.
- Epilepsy or mental disorders that hinder normal communication.
- Previous use of other treatments to control myopia progression, such as anticholinergic drugs like atropine within the past 3 months, or participation in other studies involving functional frame lenses, multifocal soft lenses, or similar interventions.
- Any other situation deemed unsuitable for participation in the study by the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, 200040
He Jiangnan, PhD, 021-62539696, hejiangnan85@126.com
About this study
Official title: Efficacy and Safety of Low-Level Monochromatic Red-Light for High Myopia Control in Adults: A Randomized, Controlled, Multicenter Clinical Trial
The purpose of this clinical study is to confirm the effectiveness and safety of low-level monochromatic red-light for high myopia control in adults
Read the detailed description
Currently, there is still a lack of effective methods for managing adult high myopia globally. The Elsing Myopia and Amblyopia Therapy Instrument, developed by Suzhou Industrial Park Zuoguan Medical Equipment Co., Ltd., has gained widespread usage in mainland China for amblyopia treatment and myopia control. This instrument utilizes low-intensity laser therapy (LLLT) for treatment, demonstrating improvements in visual acuity without any local or systemic side effects. The low-intensity laser induces photochemical reactions in the retina, such as enhancing cytochrome C oxidase activity, modulating gene expression to regulate the mitochondrial respiratory chain, and increasing the biological activity of nitric oxide. These mechanisms have been applied in the treatment of age-related macular degeneration and diabetic retinopathy. As the onset of myopia is closely linked to retinal signaling pathways, preliminary test data suggests that the instrument can significantly slow down myopia progression. This study aims to investigate the potential of low-intensity laser therapy in preventing and treating high myopia in adults, providing innovative approaches to mitigate the widespread impact of high myopia.
- Conditions
- High Myopia
- Being tested
- Myopic amblyopia comprehensive treatment instrument, Glasses
- Keywords
- High Myopia; LLLT; Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myopic amblyopia comprehensive treatment instrumentDevice
Myopic amblyopia comprehensive treatment instrument is produced by Suzhou Industrial Park Zuoguan Medical Equipment Co., LTD.
GlassesDevice
Optometry with glasses as a routine treatment
| Study group | Role | What they receive |
|---|---|---|
| Low-Level Red-Light threapy plus glasses threapy | Experimental | Myopic amblyopia comprehensive treatment equipment + conventional optometry with glasses for treatment Receives: Device: Myopic amblyopia comprehensive treatment instrument; Device: Glasses |
| glasses threapy | Experimental | conventional optometry with glasses for treatment Receives: Device: Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in axial length of the left and right eyes
The axis of the eye was assessed utilizing the IOL Master (version 5.02, Carl Zeiss, Jena, Germany), which employed simulated eye calibration prior to measurements. To ensure accuracy, three consecutive measurements were taken, and the average value was obtained. If the difference between any two measurements exceeded 0.05mm, a re-measurement was performed.
Measured: baseline, 30days, 90 days, 180 days
Secondary outcomes (1)
Changes of equivalent spherical mirror after mydriatic optometry
Based on previous experience, this instrument requires a treatment duration of 180 days to demonstrate its preventive and control effects. Therefore, the 180-day data changes will be utilized as the evaluation indicator.
Measured: baseline, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- He Jiangnan, PhD, Study director, Shanghai Eye Disease Prevention & Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947019
- Sponsor's protocol ID
- QX-2022-A-014
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-Level Monochromatic Red-Light for High Myopia Control in Adults: A Randomized, Controlled, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT05947019
- Acronym / sponsor ID
- QX-2022-A-014
- Conditions
- High Myopia
- Keywords
- High Myopia; LLLT; Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 14 Jul 2023 (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 study is to confirm the effectiveness and safety of low-level monochromatic red-light for high myopia control in adults
Detailed description
Currently, there is still a lack of effective methods for managing adult high myopia globally. The Elsing Myopia and Amblyopia Therapy Instrument, developed by Suzhou Industrial Park Zuoguan Medical Equipment Co., Ltd., has gained widespread usage in mainland China for amblyopia treatment and myopia control. This instrument utilizes low-intensity laser therapy (LLLT) for treatment, demonstrating improvements in visual acuity without any local or systemic side effects. The low-intensity laser induces photochemical reactions in the retina, such as enhancing cytochrome C oxidase activity, modulating gene expression to regulate the mitochondrial respiratory chain, and increasing the biological activity of nitric oxide. These mechanisms have been applied in the treatment of age-related macular degeneration and diabetic retinopathy. As the onset of myopia is closely linked to retinal signaling pathways, preliminary test data suggests that the instrument can significantly slow down myopia progression. This study aims to investigate the potential of low-intensity laser therapy in preventing and treating high myopia in adults, providing innovative approaches to mitigate the widespread impact of high myopia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Level Red-Light threapy plus glasses threapy | Experimental | Device: Myopic amblyopia comprehensive treatment instrument, Device: GlassesMyopic amblyopia comprehensive treatment equipment + conventional optometry with glasses for treatment |
| glasses threapy | Experimental | Device: Glassesconventional optometry with glasses for treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 40 years, regardless of gender.
- Presence of myopic refractive error in at least one eye, with myopic lens power after mydriasis exceeding 6.00D, diffusivity less than 2.00D, binocular anisometropia less than 3.00D, and best corrected distance visual acuity of at least 0.6, as well as near visual acuity of at least 0.6.
- Normal cognitive abilities and language communication skills, capable of actively cooperating with the required treatment.
- Absence of contraindications for atropine use, such as acute ocular inflammation, dry eye, keratoconus, and diabetes.
- Written informed consent obtained from the patients.
Key exclusion criteria (10 listed)
- History of photoallergy, glaucoma, trichiasis syndrome, ocular hypertension, fundus macula lesions, or eye injuries.
- Corneal curvature examination revealing an average K value of the anterior corneal surface of ≥45.
- Presence of systemic diseases (e.g., heart, liver, kidney diseases) and congenital hereditary myopia.
- Chronic eye diseases, including ocular trauma, strabismus, or previous ocular surgery, as well as allergic conjunctivitis.
- Previous internal trichiasis, severe corneal opacity, conjunctival infection, or other eye diseases.
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 |
|---|---|---|
| Myopic amblyopia comprehensive treatment instrumentMyopic amblyopia comprehensive treatment instrument is produced by Suzhou Industrial Park Zuoguan Medical Equipment Co., LTD. | Device | Low-Level Red-Light threapy plus glasses threapy |
| GlassesOptometry with glasses as a routine treatment | Device | Low-Level Red-Light threapy plus glasses threapy, glasses threapy |
Primary outcome
Change from baseline in axial length of the left and right eyes
Time frame: baseline, 30days, 90 days, 180 days
The axis of the eye was assessed utilizing the IOL Master (version 5.02, Carl Zeiss, Jena, Germany), which employed simulated eye calibration prior to measurements. To ensure accuracy, three consecutive measurements were taken, and the average value was obtained. If the difference between any two measurements exceeded 0.05mm, a re-measurement was performed.
1 secondary outcome
Changes of equivalent spherical mirror after mydriatic optometry
Time frame: baseline, 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No
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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.
He Jiangnan, PhD study director
Shanghai Eye Disease Prevention & 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 Myopic amblyopia comprehensive treatment instrument and Glasses in people with High 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 5 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: status not confirmed, as of the sponsor's last update on 14 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact He Jiangnan (021-62539696, hejiangnan85@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in axial length of the left and right eyes (time frame: baseline, 30days, 90 days, 180 days). 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 14 Jul 2023.