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Clinical observation on efficacy and safety of 0.01% atropine combined with multi-point myopia defocusing lens in the treatment of myopia in children

Clinical observation on efficacy and safety of 0.01% atropine combined with multi-point myopia defocusing lens in the treatment of myopia in children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034778
Enrollment
Unknown
Registered
2020-07-18
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-07-27

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

Conditions

eye disease

Interventions

Group A:Plain frame glasses
Group B:General frame +0.01% atropine 1 time before going to bed
Group C:Normal frame +0.01% atropine before going to sleep 2 times
Group D:DIMS frame lens +0.01% atropine one time before going to bed

Sponsors

Shenyang Xingqi Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1) Binocular BCVA >= 0.8, binocular near vision and normal regulation ability; 2) Dioptric examination: ball mirror degree -1.00 ~ -6.00d, regular astigmatism 0.2); 4) Pupil size 2. 5 ~ 4mm;

Exclusion criteria

Exclusion criteria: 1) Patients with ocular or systemic diseases are not suitable for atropine eye drops; 2) Patients with systemic diseases should take long-term medication (such as hormones, atropine, non-steroidal anti-inflammatory drugs, etc.) or use the treatment plan that affects the change of myopia degree during the observation period; 3) Poor near vision and abnormal regulation ability; 4) Nearly 3MO patients who have worn contact lens or applied other relevant treatment measures; 5) Poor compliance, unable to cooperate with the examination, treatment on time or come to the hospital for review at regular intervals; 6) Patients with allergies to related drugs.

Design outcomes

Primary

MeasureTime frame
refractive diopter;length of optic axis;

Secondary

MeasureTime frame
pupil diameter;Regulating aggregate capacity;IOP (intraocular pressure);

Countries

China

Contacts

Public ContactGao Xu

Bishan People's Hospital of Chongqing

gaoxu61466850@qq.com+86 15213157071

Outcome results

None listed

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