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

Ruihua Wei

Status: Not yet enrolling

Conditions: Myopia

Treatments: Device: Airdoc Sky-n1201; Device: Eyerising RS-200-2A

Study type: Interventional

Funder types: Other

Identifiers

NCT07186088

2025YK-54

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 2 patient groups

The Laser Group

Experimental group

Description:

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

Treatment:

Device: Eyerising RS-200-2A

The LED Group

Experimental group

Description:

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

Treatment:

Device: Airdoc Sky-n1201