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Evaluation of the Efficacy and Safety of a Dual-Surface Composite Myopia Management Lens in Clinical Application

Evaluation of the Efficacy and Safety of a Dual-Surface Composite Myopia Management Lens in Clinical Application

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128137
Enrollment
Unknown
Registered
2026-07-14
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

Myopia, astigmatism

Interventions

Experimental group:Prescribing and fitting dual-surface composite myopia management 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 6~14 years old, gender is not limited; 2.Computer optometry after ciliary muscle paralysis to detect binocular equivalent bulb photometry between -0.50D and -6.00D (including -0.50D and -6.00D); 3.After ciliary muscle paralysis, the astigmatism of both eyes was detected by computer optometry <=2.0D; 4.The anisometropia of both eyes was less than 2.00D after ciliary muscle paralysis; 5.Normal intraocular pressure in both eyes (<=21mmHg); 6.The best corrected far vision at any one glance is better than or equal to 1.0; 7.There was no amblyopia or any other ocular pathological changes in both eyes; 8.The patient clearly understands and voluntarily participates in the study, and the informed consent is signed by the patient and the parent/guardian;

Exclusion criteria

Exclusion criteria: 1.One eye met the inclusion criteria; 2.Have any eye or systemic disease that may be associated with the development of myopia or affect the refractive state of the eye (such as congenital cataracts, retinopathy of prematurity, Marfan syndrome, diabetes, etc.), or medications for the disease that affect vision; 3.Dominant strabismus or apparent binocular vision dysfunction is present; 4.Unwilling to cooperate with visitors; 5.Within one month, the following treatments for myopia control were used: atropine or other antimuscarinic drugs, bifocal/progressive or multifocal contact lenses, bifocal/progressive or multifocal frame glasses, orthokeratology lenses, rigid gas-permeable or other types of corneal contact lenses used to delay the progression of myopia. 6.The investigator determined that the patient was not suitable for other conditions for inclusion;

Design outcomes

Primary

MeasureTime frame
Axial length;Diopter number;

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: Jul 23, 2026