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A randomized controlled trial to evaluate the efficacy and safety of a myopia prevention and control lens with a micro-nano structure for delaying the progression of myopia in children

A randomized controlled trial to evaluate the efficacy and safety of a myopia prevention and control lens with a micro-nano structure for delaying the progression of myopia in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107724
Enrollment
Unknown
Registered
2025-08-18
Start date
2025-08-23
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

Myopia

Interventions

Experimental group:Fit myopia prevention and control lenses with micro-nano structures
Control group:Fitting ordinary single-light lenses

Sponsors

Bejing Tongren Hospital, Capital Medical Uniersity
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1.Age: 6 to 14 years old, gender not limited; 2.The refractive status meets the following conditions: a) The equivalent spherical dioptometry of both eyes detected by computerized refraction after ciliary muscle paralysis is between -0.50D and -6.00D (including -0.50D and -6.00D); b) After ciliary muscle paralysis, the astigmatism of both eyes detected by computerized refraction was <=2.0D. c) After ciliary muscle paralysis, the anisometropia of both eyes detected by computerized refraction is <=2.00D; 3.Intraocular pressure in both eyes is normal (greater than or equal to 10mmHg, less than or equal to 21mmHg); 4.The best corrected distant visual acuity of either eye is better than or equal to 1.0; 5.There is no amblyopia in both eyes or any other pathological changes of the eyeballs; 6.The patient himself/herself clearly understood and voluntarily participated in this study, and the informed consent form was signed by himself/herself and his/her parents/guardians;

Exclusion criteria

Exclusion criteria: 1.There are any ocular or systemic diseases that may be related to the development of myopia or affect the refractive state of the eye (such as congenital cataracts, retinopathy of prematurity, Marfan syndrome, diabetes, etc.), or the drug treatment of the disease may affect vision; 2.There is explicit strabismus or obvious binocular visual function abnormalities; 3.Unwilling to cooperate with the visitor; 4.Other circumstances under which the researcher judged that the patient was not suitable for inclusion;

Design outcomes

Primary

MeasureTime frame
Fundus indicators;Intraocular pressure;Diopter;Axial length of the eye;

Countries

China

Contacts

Public ContactLei Tian

Bejing Tongren Hospital, Capital Medical Uniersity

tianlei0131@163.com+86 18600166885

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026