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Not yet recruitingNCT07186088Updated Sep 22, 2025

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

An interventional study of Eyerising RS-200-2A and Airdoc Sky-n1201 in Myopia, sponsored by Ruihua Wei. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Ruihua Wei · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

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 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.

02

Conditions studied

  • Myopia

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03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    The Laser Group

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

    Device: Eyerising RS-200-2A

  • Experimental
    The LED Group

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

    Device: Airdoc Sky-n1201

Interventions

  • DeviceEyerising RS-200-2A

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

  • DeviceAirdoc Sky-n1201

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

05

What researchers measure

Primary outcomes

  1. Axial length

    Time frame: From enrollment to the end of treatment up to 7 months

Secondary outcomes

  1. Spherical equivalent

    Time frame: From enrollment to the end of treatment up to 7 months

  2. Choroidal thickness

    Time frame: From enrollment to the end of treatment up to 7 months

06

Study locations

1 site
  • Tianjin Medical University Eye Hospital
    Tianjin, Tianjin Municipality 120120, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07186088
Lead sponsor
Ruihua Wei
Collaborators
Tianjin Medical University Eye Hospital
Responsible party
Ruihua Wei (Professor, Tianjin Medical University Eye Hospital) — Sponsor-investigator
First posted
Sep 22, 2025
Start date
Sep 20, 2025 (estimated)
Primary completion
Mar 20, 2026 (estimated)
Completion
Jun 20, 2026 (estimated)
Last update
Sep 22, 2025

Study contacts

Guihua Liu
Contact
liuguihua1992@163.com
+8686428756
Ruihua Wei
principal investigator · Tianjin Medical University Eye Hospital, Tianjin, Tianjin 120120 Recruiting

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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