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Randomized controlled trial to evaluate the effectiveness and safety of a composite lens designed based on longitudinal chromatic aberration for delaying myopia progression in children

Randomized controlled trial to evaluate the effectiveness and safety of a composite lens designed based on longitudinal chromatic aberration for delaying myopia progression in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100443
Enrollment
Unknown
Registered
2025-04-09
Start date
2025-04-12
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

myopia

Interventions

Test group 2:Fitted with defocusing lenses
Test group 1:Matching of composite lenses based on longitudinal chromatic aberration design

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.People who are allergic to cycloplegics or their components (atropine, cyclopentone, pramecaine, or benzalkonium chloride) used during the examination of this study; 2.Either eye has an abnormality of the refractive system, such as keratoconus, conical lens, spherical lens, etc; 3.Diseases that may affect refractive development or easily progress to high myopia, such as Down syndrome, Marfan syndrome, retinopathy of prematurity, and hypoxic encephalopathy of newborns; 4.Other eye abnormalities and diseases affecting vision in either eye, such as ptosis, congenital corneal abnormalities, corneal leukoplakia, congenital lens abnormalities, cataracts, macular disease, choroid disease, severe vitreous opacity, retinopathy, etc; 5.Binocular or stereoscopic deficits; 6.History of glaucoma in either eye and/or shallow anterior chamber; 7.Previous or current concomitant significant strabismus, amblyopia, or nystagmus; 8.Previous eyelid, strabismus, internal eye or refractive surgery; 9.Drugs that had been used systemic or local within 3 months prior to screening, such as anticholinergic drugs: atropine and pirenzil; Cholinoid drugs: pilocarpine, etc.; Or drugs that may affect pupil size and regulation, such as belladonna tablets, morphine, or sedative sleeping pills; 10.Myopic control treatments, including atropine or other antimuscarinic drugs, bifocal/progressive or multifocal contact lenses, bifocal/progressive or multifocal frame glasses, orthokeratology lenses, rigid permeable or other contact lenses used to delay myopic progression, have been used within one month; 11.Previous or current systemic diseases: immune system diseases, central nervous system diseases, asthma, diabetes, severe cardiopulmonary dysfunction, severe liver and kidney dysfunction; 12.Participated in other clinical trials within 3 months prior to randomization; 13.Unable to participate in the study voluntarily or with low motivation; 14.Unable to cooperate with regular follow-up and various examinations; 15.Lack of expression; 16.There are any other conditions that the investigator considers inappropriate to participate in this study;

Design outcomes

Primary

MeasureTime frame
Diopter number;Axis oculi;

Countries

China

Contacts

Public ContactLei Tian

Bejing Tongren Hospital, Capital Medical Uniersity

tianlei0131@163.com+86 186 0016 6885

Outcome results

None listed

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