Randomized Controlled Study on the Delay of Myopia Onset in Children at the Pre-Myopia Stage using Distant-image Screen Technology

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400082078

Enrollment

Unknown

Registered

2024-03-20

Start date

2024-08-10

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Interventions

Experiment Group 1:When reading or using electronic devices at home, the Distant-image Screen RIO-Max 2.0 should be applied.

Experiment Group 2:When reading or using electronic devices at home, use the RIO-Ultra 2.0 Distant-image Screen, optimized with optical defocus technology

The Control Group:Conventional reading or using electronic devices

Eligibility

Sex/Gender

All

Age

6 Years to 10 Years

Inclusion criteria

Inclusion criteria: (1) Age: 6 to 10 years old. (2) Under dilation, the autorefraction of either eye shows an equivalent spherical refraction of less than or equal to +0.75D and greater than -0.50D. Astigmatism does not exceed 1.50D. (3) At least one parent has a refractive error of less than or equal to -3.00D. (4) Daily near work time is >= 1 hour, including non-academic activities (TV, games, etc.), academic activities (online learning, check-ins), reading, etc.; (5) No history of contact lens wear, no previous use of any myopia control measures. (6) Naked eye vision of either eye is equal to or better than 4.9. (7) No manifest strabismus in the distant/near cover test.

Exclusion criteria

Exclusion criteria: (1) Unable to comply with the protocol to obtain reliable research measurements. (2) Presence of any ocular diseases that could affect refractive development, such as retinal diseases, cataracts, and ptosis of the upper eyelid. (3) Presence of systemic or neurodevelopmental conditions that could affect refractive development. The use of known ophthalmic or systemic medications that may affect the development of myopia or visual acuity through effects on retinal accommodative amplitude or intraocular pressure.

Design outcomes

Primary

Measure	Time frame
The prevalence of myopia;	—

Secondary

Measure	Time frame
the overall changes of cycloplegic objective refraction SER;The overall changes of axial length;	—

Countries

China

Contacts

Public ContactMeiping Xu

Eye Hospital of Wen Medical University

xmp@eye.ac.cn+86 135 8741 5286

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 12, 2026