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A randomized, controlled, double-blind study on the prevention and control of myopia in school-aged children in bright areas with multi-zone forward optical defocus lenses combined with 0.05% atropine eye drops

A randomized, controlled, double-blind study on the prevention and control of myopia in school-aged children in bright areas with multi-zone forward optical defocus lenses combined with 0.05% atropine eye drops

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048300
Enrollment
Unknown
Registered
2021-07-05
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-14

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

Conditions

Myopia

Interventions

Group 1:DIMS frame mirror + 0.05% atropine eye drops
Group 2:DIMS frame mirror + 0.1% sodium hyaluronate eye drops
Group 3:Single light frame mirror + 0.05% atropine eye drops
Group 4:Single light frame mirror + 0.1% sodium hyaluronate eye drops

Sponsors

The 7th Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 8 Years

Inclusion criteria

Inclusion criteria: 1. Students of Shenzhen Gongming No. 1 Primary School and No. 2 Primary School; 2. Between 6-8 years old; 3. Equivalent spherical lens degree -1.00D~-5.00D; 4. Astigmatism =6/6; 7. Parents or guardians can understand and agree to participate in the treatment after communicating with the doctor, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Amblyopia; 2. Squint; 3. Abnormal binocular vision; 4. Allergic to any ingredient in atropine eye drops; 5. Eye diseases: active ocular surface infectious diseases, severe dry eye syndrome, angle-closure glaucoma, ptosis and other eye diseases other than refractive errors; 6. Systemic diseases: Sjogren syndrome, heart disease, especially arrhythmia, congestive heart failure, coronary heart disease, mitral valve stenosis, etc., contraindications for the use of atropine such as reflux esophagitis; 7. Previous use of hyperfocal, bifocal or defocused frame lenses, contact lenses, orthokeratology lenses or received medical myopia treatment.

Design outcomes

Primary

MeasureTime frame
Best corrected visual acuity;Axial length;Pupil size;Refraction;Choroidal thickness;

Countries

China

Contacts

Public ContactPeng Hongjun

The 7th Affiliated Hospital, Sun Yat-Sen University

Hpeng77@outlook.com+86 18138202103

Outcome results

None listed

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