Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies

NCT ID: NCT07186088

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-20

Study Completion Date

2026-06-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To explore the effectiveness and safety of repeated exposure to repeated low-intensity red light

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The experiment will be divided into two phases. In the first phase, the subjects will be randomly grouped using laser equipment and LED equipment, and each 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

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The Laser Group

Use Eyerising (RS-200-2A), 1 time,2 times or 3 times a day

Group Type EXPERIMENTAL

Eyerising RS-200-2A

Intervention Type DEVICE

Eyerising RS-200-2A,1 time,2 times, 3 times a day

The LED Group

Use Airdoc (Sky-n1201), 2 times a day

Group Type EXPERIMENTAL

Airdoc Sky-n1201

Intervention Type DEVICE

Eyerising RS-200-2A,2 times a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Eyerising RS-200-2A

Eyerising RS-200-2A,1 time,2 times, 3 times a day

Intervention Type DEVICE

Airdoc Sky-n1201

Eyerising RS-200-2A,2 times a day

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18-35 years old, gender not limited; Obtained informed consent.

Exclusion Criteria

* 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)
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tianjin Medical University Eye Hospital

OTHER

Sponsor Role collaborator

Ruihua Wei

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ruihua Wei

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ruihua Wei

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Eye Hospital, Tianjin, Tianjin 120120 Recruiting

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Guihua Liu

Role: CONTACT

+8686428756

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Guihua Liu

Role: primary

8686428756

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025YK-54

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.