Efficacy and Safety of 1% Atropine "5+3" Regimen in Children and Adolescents Controlling Myopia

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Studies have shown that atropine eye drops are effective in controlling myopia in children and adolescents. 1% atropine ophthalmic drug has obvious curative effect for controlling myopia, but its side effects such as photophobia and blurred vision limit its popularization and use. In the early stage, our research group used 1% atropine "5+3" myopia control program and 1% atropine alternate eye myopia control program. Retrospective clinical research data showed that it could significantly reduce side effects and improve use compliance, but there is currently no evidence from prospective clinical studies.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Treatments: Atropine

Criteria

Inclusion Criteria:

• 1. Age 6 to 12 years old; 2. Both eyes are in line with the diagnosis of myopic refractive error and 0.25D < myopia spherical lens <4.00D after mydriasis, astigmatism <2.00D, binocular anisometropia <3.00D, and the best corrected distance vision is at least 0.8, myopia The force is at least 0.8; 3. Visual function: Timus≤100 seconds, exophoria <5△, accommodation amplitude (AMP) ≥ age-related minimum accommodation amplitude value (minimum accommodation amplitude=15-0.25×age); 4. No contraindications for atropine treatment such as acute eye inflammation, dry eye, keratoconus, diabetes, etc.; 5. The written informed consent of the guardian and the child himself.

Exclusion Criteria:

• 1. History of photosensitivity, glaucoma, blue eye syndrome, ocular hypertension, fundus macular lesions or damage; 2. Corneal curvature examination, the average K value of the anterior surface of the cornea is ≥45; 3. Patients with ocular trauma, oblique or surgical eyes, atopic keratoconjunctivitis and other chronic eye diseases;

4. Those with previous ophthalmia, severe angular, conjunctival infection and other eye diseases; 5. Patients with neurological diseases and allergic or contraindications to atropine or other therapeutic drugs; 6. Received other treatments to control the development of myopia in the past, such as the use of anticholinergic drugs such as atropine within 3 months, or participated in other relevant researchers such as functional frame mirrors and multifocal flexible mirrors; 7. Other circumstances judged by the investigator to be unsuitable to participate in the research.