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Not yet recruiting NCT07186088

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

No phase Interventional Myopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eyerising RS-200-2A, Airdoc Sky-n1201.
Who it may be relevant to
Registry conditions: Myopia. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Study on the Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies for Adult Myopia Treatment

Overview

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 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.

Interventions

  • Device Eyerising RS-200-2A
    Eyerising RS-200-2A,1 time,2 times, 3 times a day
  • Device Airdoc Sky-n1201
    Eyerising RS-200-2A,2 times a day

Primary outcome measures

  • Axial length [Time frame: From enrollment to the end of treatment up to 7 months]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University Eye Hospital — Tianjin

Identifiers

NCT: NCT07186088 · 2025YK-54

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗