Evaluating the effects of different doses of atropine on myopia in children
Shanghai Eye Disease Prevention and Treatment Center
NA · Shanghai Eye Disease Prevention and Treatment Center · NCT04699357
This study is testing different strengths of atropine eye drops to see if they can help slow down worsening eyesight in children with high myopia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 357 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Shanghai Eye Disease Prevention and Treatment Center (other) |
| Locations | 3 sites (Shanghai, Shanghai and 2 other locations) |
| Trial ID | NCT04699357 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of various concentrations of atropine eye drops in slowing the progression of high myopia in children. Participants will be divided into three groups, receiving 0.01%, 0.04%, or 0.1% atropine drops nightly for two years, with parental supervision to ensure compliance. The study will also monitor any adverse reactions and the rate of myopia regression associated with each concentration. The trial is multi-centered, taking place at several hospitals in Shanghai.
Who should consider this trial
Good fit: Ideal candidates are children with high myopia who have shown progression of more than 0.5D in the past year and meet specific visual acuity and health criteria.
Not a fit: Patients with certain eye diseases, systemic conditions, or those allergic to atropine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for controlling myopia progression in children.
How similar studies have performed: Previous studies have indicated that atropine can be effective in managing myopia, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The BCVA of distant vision is at least 0.5, near vision is at least 1.0, Titmus stereo vision is less than 80 seconds, far exotropia is less than 10 prism degrees, far esotropia 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 actively cooperate with the treatment as required; * Written informed consent of guardian and child. Exclusion Criteria: * Diseases of the study eye: keratitis, keratoconus, congenital cataract, glaucoma, fundus diseases; present situation with anterior segment or posterior segment inflammation, such as acute conjunctivitis, iridocyclitis; * Systemic diseases affecting drug use: albinism, epilepsy, serious mental and neurological 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, including anticholinergic drugs such as atropine, or participated in other functional frame lens, multifocal soft lens in the past one year; * Other situations that not suitable for participating in the trial as judged by the researcher
Where this trial is running
Shanghai, Shanghai and 2 other locations
- Shanghai Eye Disease Prevention & Treatment Center — Shanghai, Shanghai, China (RECRUITING)
- Shanghai General Hospital — Shanghai, China (RECRUITING)
- Shanghai Ninth People's Hospital — Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Xun Xu, MD
- Email: drxuxun@sjtu.edu.cn
- Phone: +86-021-63240090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: High Myopia