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Precise Intervention of Progressive Myopia in Children, Adolenscents and Young Adults—A Randomized Clinical Trial

Precise Intervention of Progressive Myopia in Children, Adolenscents and Young Adults—A Randomized Clinical Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037113
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-05

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

Conditions

Myopia

Interventions

Children and Adolenscents A group:0.01% atropine
Children and Adolenscents B group:1% atropine
Children and Adolenscents C group:Combination use of orthokeratology and 0.01% atropine
Children and Adolenscents D group:Combination use of orthokeratology and 1% atropine
Young Adults A group:0.01% atropine
Young Adults B group:Defocus incorporated multiple segments spectacle lens
Young Adults C group:Combination use of defocus incorporated multiple segments spectacle lens and 0.01% atropine
Young Adults D group:Ordinary glass

Sponsors

Jianfeng Zhu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 29 Years

Inclusion criteria

Inclusion criteria: 1. Progressive myopia in children and adolescents The written informed consent signed by parents (legal representative) and the child himself has been obtained; Age: 8-15 years old; The results of binocular computer optometry after mydriasis met the following requirements: 8-9 years old: - 6.00 d ~ - 2.00 D; 10 years old: - 6.00 d ~ - 3.00 D; 11-12 years old: - 6.00 d ~ - 4.00 D; 13-15 years old: - 6.00 d ~ - 5.00 D. Astigmatism >= - 1.5 D, anisometropia (based on equivalent spherical lens power) = 26mm, astigmatism >= - 1.5D, anisometropia (based on equivalent spherical lens power) <= 1.50D; Pathological myopia was found in fundus photography.

Exclusion criteria

Exclusion criteria: 1. Patients with eye diseases that may affect vision or ametropia (cataract and other lens injury diseases, glaucoma, macular disease, corneal disease, uveitis, retinal detachment, severe vitreous opacity, etc.) history. 2. Patients with systemic diseases: immune system diseases, central nervous system diseases, Down's syndrome, asthma, severe cardiopulmonary function, severe liver and kidney dysfunction. 3. Patients with any eye disease that is prohibited from atropine or other anticholinergic eye preparations. 4. Patients with dominant strabismus or any other pathological changes of the eyeball. 5. Patients with binocular hyperopia whose visual acuity could not be corrected to LogMAR 0.1. 6. Patients who use anticholinergic drugs within one month, such as atropine or pirenzie, and cholinergic drugs such as pilocarpine (except for rapid mydriasis). 7. Patients who used orthokeratology lens, multifocal soft lens and functional frame glasses within 1 month. 8. Patients who are allergic to atropine, cyclopentolate and other drugs used in this study. 9. Patients who have participated in clinical trials of other drugs within 3 months. 10. Other situations considered unsuitable by the researcher.

Design outcomes

Primary

MeasureTime frame
Spherical equivalent;axial length;

Secondary

MeasureTime frame
choroidal thickness;choroidal vessel index;retinal vessel density;Peripapillary atrophy;

Countries

China

Contacts

Public ContactJianfeng Zhu

Shanghai Eye Disease Prevention and Treatment Center

jfzhu1974@hotmail.com+86 13501822932

Outcome results

None listed

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