MyopiaAO-SLONCT07160036
Repeatability of AO-SLO (Mona IIa) Technology and Cone Cell Density of Individuals Use Repeated Low-level Red-light Therapy
A study testing RLRL(Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China)) in people with Myopia, run by Ruihua Wei at 1 site in China.
Trial summary
To explore the repeatability of AO-SLO (Mona IIa) technology and the difference of cone cell density between individuals who used or not used repeated low-intensity red light treatment Read more about this study
- Who is it for?
- Ages 6 to 55 years
- Conditions the study is for
- Myopia
- What is being tested?
- RLRL(Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China))
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2025to 20 Dec 2025
- 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 6 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 6 - 55 years old, gender not limited; Obtained informed consent.
Who cannot join
- Children with 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, 1 recruiting
- Recruiting
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 120120
Guihua Liu, 8686428756, liuguihua1992@163.com
About this study
Official title: Exploring the Repeatability of Adaptive Optics Scanning Laser Ophthalmoscope Technology (AO-SLO Mona IIa) and the Differences in Cone Cell Density Between Individuals Who Undergone and Not Undergone Repeated Low-level Red-light
To explore the repeatability of AO-SLO (Mona IIa) technology and the difference of cone cell density between individuals who used or not used repeated low-intensity red light treatment
Read the detailed description
This study focuses on the population with long-term use of repetitive low-intensity myopia, exploring the safety of repetitive low-intensity red light over a long period of use, and providing data support and clinical guidance for the field of repetitive low-intensity red light. It investigates the repeatability of adaptive optics scanning laser ophthalmoscope technology and observes the safety of repetitive low-intensity red light treatment for children over a long period of use.
- Conditions
- Myopia
- Being tested
- RLRL(Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China))
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLRL(Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China))Device
use RLRL twice a day
| Study group | Role | What they receive |
|---|---|---|
| RLRL group | Experimental | Use RLRL (Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China) Receives: Device: RLRL(Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China)) |
| No RLRL Group | No intervention | No use RLRL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The density of cone cells
Measured: From enrollment to the end of treatment at 3 weeks
Secondary outcomes (1)
Repeatability of adaptive optics scanning laser ophthalmoscope technology of cone cell density
Measured: From enrollment to the end of treatment at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Dec 2025 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 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
- NCT07160036
- Sponsor's protocol ID
- 2025YK-52
- Acronym
- AO-SLO
- Status last verified
- Sep 2025
- First submitted
- 30 Aug 2025
- Last updated
- 15 Sep 2025
- 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Repeatability of Adaptive Optics Scanning Laser Ophthalmoscope Technology (AO-SLO Mona IIa) and the Differences in Cone Cell Density Between Individuals Who Undergone and Not Undergone Repeated Low-level Red-light
- ClinicalTrials.gov ID
- NCT07160036
- Acronym / sponsor ID
- AO-SLO / 2025YK-52
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ruihua WeiUniversity, hospital or other
- Collaborators
- Tianjin Medical University Eye Hospital
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 8 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 repeatability of AO-SLO (Mona IIa) technology and the difference of cone cell density between individuals who used or not used repeated low-intensity red light treatment
Detailed description
This study focuses on the population with long-term use of repetitive low-intensity myopia, exploring the safety of repetitive low-intensity red light over a long period of use, and providing data support and clinical guidance for the field of repetitive low-intensity red light. It investigates the repeatability of adaptive optics scanning laser ophthalmoscope technology and observes the safety of repetitive low-intensity red light treatment for children over a long period of use.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RLRL group | Experimental | Device: RLRL(Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China))Use RLRL (Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China) |
| No RLRL Group | No intervention | –No use RLRL |
Who may qualify
- Ages
- 6 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 6 - 55 years old, gender not limited; Obtained informed consent.
Key exclusion criteria (11 listed)
- Children with 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 |
|---|---|---|
| RLRL(Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China))use RLRL twice a day | Device | RLRL group |
Primary outcome
The density of cone cells
Time frame: From enrollment to the end of treatment at 3 weeks
1 secondary outcome
Repeatability of adaptive optics scanning laser ophthalmoscope technology of cone cell density
Time frame: From enrollment to the end of treatment at 3 weeks
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 15 Sep 2025.
- 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 RLRL(Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China)) 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: looking for participants now, as of the sponsor's last update on 15 Sep 2025. 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?
Contact Guihua Liu (+8686428756, liuguihua1992@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The density of cone cells (time frame: From enrollment to the end of treatment at 3 weeks). 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 15 Sep 2025.