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A randomized controlled trial to evaluate the efficacy and safety of bifacially compound defocus lenses combined with binocular treatment in delaying the progression of myopia in children

A randomized controlled trial to evaluate the efficacy and safety of bifacially compound defocus lenses combined with binocular treatment in delaying the progression of myopia in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114495
Enrollment
Unknown
Registered
2025-12-12
Start date
2025-12-13
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Myopia

Interventions

Experimental Group 1:Fit bifocal composite defocus lenses
Experimental Group 2:Fit bifocal composite defocus 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.The refractive status met the following conditions: a) After ciliary muscle paralysis, the equivalent spherical photometry of both eyes was between -0.50D and -6.00D (including -0.50D and -6.00D); b) After ciliary muscle paralysis, astigmatism in both eyes was =10mmHg, <=21mmHg); 4.The best corrected far vision at any one glance is better than or equal to 1.0; 5.There was no amblyopia or any other ocular pathological changes in both eyes; 6.Parents/guardians understand the scheme and are willing to accept random grouping; 7.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.Those who are allergic to the mydriatic agents used in this research (such as atropine, cyclopentolate, procaine, or benzalkonium chloride) or their components; 2.Either eye may have an abnormality of the refractive system, such as keratoconus, conical lens, spherical lens, etc. 3.Diseases that may affect the development of refractive errors or are prone to progressing to high myopia, such as: Down syndrome, Marfan syndrome, retinopathy of prematurity, neonatal hypoxic-ischemic encephalopathy patients, etc. 4.Either eye may have other ocular abnormalities or diseases that affect vision, such as ptosis of the upper eyelid, congenital abnormalities of the cornea, corneal leukoma, congenital lens abnormalities, cataract, macular degeneration, choroidal lesion, severe vitreous opacity, retinal lesion, etc. 5.Either eye has a history of glaucoma and/or has a shallow anterior chamber. 6.Previous or current conditions include obvious strabismus, amblyopia or nystagmus. 7.Those who have used drugs that may affect the evaluation of therapeutic effect within the past 3 months, either systemically or locally, are excluded. Such drugs include anticholinergic drugs such as atropine and pilocarpine; muscarinic drugs such as physostigmine; or drugs that may affect pupil size and accommodation, such as atropine tablets, morphine or sedative-hypnotic drugs. 8.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. 9.History or current presence of systemic diseases: immune system disorders, central nervous system disorders, asthma, diabetes, severe cardiac or pulmonary dysfunction, severe liver or kidney dysfunction. 10.Unable to voluntarily participate in this study or having low enthusiasm; 11.Unable to cooperate with regular follow-ups and various examinations; 12.The researchers believe that there are any other circumstances that would disqualify one from participating in this trial.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Visual function examination;

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