Last updated: January 10, 2022
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Myopia
Treatment
N/AClinical Study ID
NCT04699357
SHDC12019111
Ages 6-12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The BCVA of distant vision is at least 0.5, near vision is at least 1.0, Titmus stereovision is less than 80 seconds, far exotropia is less than 10 prism degrees, faresotropia is less than 6-8 prism degrees, and astigmatism is equal to or less than - 2.50 D;
- Myopia progressed more than 0.5D in the past year;
- Have normal thinking and language communication skills, and be able to activelycooperate with the treatment as required;
- Written informed consent of guardian and child.
Exclusion
Exclusion Criteria:
- Diseases of the study eye: keratitis, keratoconus, congenital cataract, glaucoma,fundus diseases; present situation with anterior segment or posterior segmentinflammation, such as acute conjunctivitis, iridocyclitis;
- Systemic diseases affecting drug use: albinism, epilepsy, serious mental andneurological diseases, congenital heart disease, arrhythmia;
- Atropine allergy;
- Very low birth weight infants with birth weight less than 1500g;
- Receiving other treatment to control the development of myopia, includinganticholinergic drugs such as atropine, or participated in other functional framelens, multifocal soft lens in the past one year;
- Other situations that not suitable for participating in the trial as judged by theresearcher
Study Design
Total Participants: 357
Study Start date:
July 04, 2021
Estimated Completion Date:
August 01, 2025
Connect with a study center
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai 200040
ChinaActive - Recruiting
Shanghai General Hospital
Shanghai,
ChinaActive - Recruiting
Shanghai Ninth People's Hospital
Shanghai,
ChinaActive - Recruiting
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