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A randomized controlled trial to evaluate the efficacy and safety of bifacially compound defocus lenses in delaying the axial elongation and refractive changes of children with mild hyperopia

A randomized controlled trial to evaluate the efficacy and safety of bifacially compound defocus lenses in delaying the axial elongation and refractive changes of children with mild hyperopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113728
Enrollment
Unknown
Registered
2025-12-02
Start date
2025-12-15
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Mild hyperopia

Interventions

Experimental group 2:Fit double-sided composite lenses
Control group:Prescription for single-vision lenses
Experimental group 1:Fit bifocal lenses with built-in diopter deviation

Sponsors

Bejing Tongren Hospital, Capital Medical Uniersity
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 6–14 years, any gender; 2. Refractive status meets the following criteria: (1) After cycloplegia, computerized refraction shows an equivalent spherical diopter in both eyes between 2.00D and 0D (inclusive); (2) After cycloplegia, computerized refraction shows astigmatism in both eyes = 1.0; 5. No amblyopia or other pathological changes in either eye; 6. Parents/guardians understand the plan and are willing to accept random group assignment; 7. The patient fully understands and voluntarily participates in this study, and both the patient and the parents/guardians have signed the informed consent form.

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;Diopter;Axial length of the eye;Intraocular pressure;Slit lamp inspection;

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