MyopiaNCT07186088
Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
A study testing Eyerising RS-200-2A and Eyerising SLX-1A in people with Myopia, run by Ruihua Wei at 1 site in China.
Trial summary
To explore the effectiveness and safety of repeated exposure to repeated low-intensity red light Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Myopia
- What is being tested?
- Eyerising RS-200-2A and Eyerising SLX-1A
- 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
- 20 Sep 2025to 31 Dec 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-35 years old, gender not limited; Obtained informed consent.
Who cannot join
- Obvious strabismus and amblyopia
- With congenital eye disease, such as congenital cataract, congenital retinal disease
- Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
- Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
- Refractive medium opacity (such as corneal disease, crystal opacity, etc.)
- Bnormal intraocular pressure and clinical significance (IOP <10 mmHg or IOP>21mmHg or binocular IOP difference ≥5mmHg)
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- Fundus chorioretinopathy (except for high myopia fundus degenerative changes) or other intraocular diseases
- Optic nerve damage or congenital optic nerve dysfunction
- Can not be regularly checked
- The adjustment range is less than 8D or obvious near difficulties
- Other reasons researchers think it is not suitable for inclusion in researchers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 120120
About this study
Official title: Study on the Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies for Adult Myopia Treatment
To explore the effectiveness and safety of repeated exposure to repeated low-intensity red light
Read the detailed description
The experiment will be divided into two phases. In the first phase, the subjects will be randomly grouped using laser equipment, LED equipment and control group. Each experimental group will be exposed to the red light twice a day for one month. The second stage involves self-comparison of the laser equipment, with the usage frequencies being once a day and three times a day.
To explore the effectiveness and safety of repeated exposure to repeated low-intensity red light in different devices and frequencies, as well as its impact on the axial length, spherical equivalent refraction and choroidal thickness of myopia progression.
- Conditions
- Myopia
- Being tested
- Eyerising RS-200-2A, Eyerising SLX-1A
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyerising RS-200-2ADevice
Eyerising RS-200-2A,1 time,2 times, 3 times a day
Eyerising SLX-1ADevice
Eyerising SLX-1A, 2 times a day
| Study group | Role | What they receive |
|---|---|---|
| The Laser Group | Experimental | Use Eyerising (RS-200-2A), 1 time,2 times or 3 times a day Receives: Device: Eyerising RS-200-2A |
| The LED Group | Experimental | Use Eyerising(SLX-1A), 2 times a day Receives: Device: Eyerising SLX-1A |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
Measured: From enrollment to the end of treatment up to 7 months
Secondary outcomes (2)
Spherical equivalent
Measured: From enrollment to the end of treatment up to 7 months
Choroidal thickness
Measured: From enrollment to the end of treatment up to 7 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 2025
- Study start20 Sep 2025
- Primary completion20 Jun 2026
- Study completion31 Dec 2026 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruihua Wei
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University Eye Hospital
- Responsible party
- Sponsor-investigator, Ruihua Wei, Tianjin Medical University Eye Hospital
- Investigators
- Ruihua Wei, Principal investigator, Tianjin Medical University Eye Hospital, Tianjin, Tianjin 120120 Recruiting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186088
- Sponsor's protocol ID
- 2025YK-54
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2025
- Last updated
- 29 Oct 2026
- 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies for Adult Myopia Treatment
- ClinicalTrials.gov ID
- NCT07186088
- Acronym / sponsor ID
- 2025YK-54
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ruihua WeiUniversity, hospital or other
- Collaborators
- Tianjin Medical University Eye Hospital
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Sep 2025 (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 and safety of repeated exposure to repeated low-intensity red light
Detailed description
The experiment will be divided into two phases. In the first phase, the subjects will be randomly grouped using laser equipment, LED equipment and control group. Each experimental group will be exposed to the red light twice a day for one month. The second stage involves self-comparison of the laser equipment, with the usage frequencies being once a day and three times a day.
To explore the effectiveness and safety of repeated exposure to repeated low-intensity red light in different devices and frequencies, as well as its impact on the axial length, spherical equivalent refraction and choroidal thickness of myopia progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Laser Group | Experimental | Device: Eyerising RS-200-2AUse Eyerising (RS-200-2A), 1 time,2 times or 3 times a day |
| The LED Group | Experimental | Device: Eyerising SLX-1AUse Eyerising(SLX-1A), 2 times a day |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-35 years old, gender not limited; Obtained informed consent.
Key exclusion criteria (11 listed)
- Obvious strabismus and amblyopia
- With congenital eye disease, such as congenital cataract, congenital retinal disease
- Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
- Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
- Refractive medium opacity (such as corneal disease, crystal opacity, etc.)
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 |
|---|---|---|
| Eyerising RS-200-2AEyerising RS-200-2A,1 time,2 times, 3 times a day | Device | The Laser Group |
| Eyerising SLX-1AEyerising SLX-1A, 2 times a day | Device | The LED Group |
Primary outcome
Axial length
Time frame: From enrollment to the end of treatment up to 7 months
2 secondary outcomes
Spherical equivalent
Time frame: From enrollment to the end of treatment up to 7 months
Choroidal thickness
Time frame: From enrollment to the end of treatment up to 7 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 29 Oct 2026.
- 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.
Ruihua Wei principal investigator
Tianjin Medical University Eye Hospital, Tianjin, Tianjin 120120 Recruiting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eyerising RS-200-2A and Eyerising SLX-1A in people with Myopia, run by Ruihua Wei 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 1 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 29 Oct 2026. 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?
Axial length (time frame: From enrollment to the end of treatment up to 7 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 29 Oct 2026.