Using low concentration atropine to prevent myopia in children
A Double-blind, Randomized Controlled Study of Low Concentration Atropine in the Prevention of Myopia in Pre-myopia Children.
This study is testing if low doses of atropine eye drops can help prevent myopia in children aged 6-9 who are at risk of developing it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 428 (estimated) |
| Ages | 6 Years to 9 Years |
| Sex | All |
| Sponsor | Shanghai Eye Disease Prevention and Treatment Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05939882 on ClinicalTrials.gov |
What this trial studies
This double-blind, randomized controlled clinical study evaluates the effectiveness and safety of low concentration atropine in preventing myopia in children aged 6-9 years who are pre-myopic. Participants are randomly assigned to receive one of three different concentrations of atropine (0.01%, 0.02%, 0.04%) or a placebo, with daily eye drop administration for one year. The study aims to determine the incidence of myopia and control refractive and axial progression in these children. The research also seeks to explore any dose-response relationship between the different concentrations of atropine used.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6-9 years who are pre-myopic and have a family history of myopia.
Not a fit: Patients with existing ocular abnormalities, such as strabismus or amblyopia, or those with a history of eye surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive treatment option for myopia in children, potentially reducing the incidence and progression of this common vision condition.
How similar studies have performed: Previous studies have shown promising results with atropine in myopia management, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The age of the screening stage is 6-9 years, both sexes; 2. One eye met the diagnosis of pre-myopia, the spherical equivalent was between -0.50D and +0.75D, the astigmatism was ≥-1.50D, and the best corrected far vision was at least 1.0; 3. At least one of parents suffers from myopia (SE of at least one eye \<=-3.00D); 4. Parents have signed informed consent and agree to participate in screening and follow-up. Exclusion Criteria: 1. Parents disagree to sign the informed consent; 2. Presence of strabismus, amblyopia, or other ocular abnormalities, or have a history of eye surgery; 3. Presence of other eye or systemic diseases; 4. Allergies to low concentration atropine or sulfuric acid drugs; 5. Histories of using other preventive measures, such as using red light within 6 months or atropine within 1 month; 6. Presence of other situations that the researchers think is not appropriate for patients to be included in the project.
Where this trial is running
Shanghai, Shanghai
- Xiangui He — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Xiangui He
- Email: xianhezi@163.com
- Phone: +8615000755422
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.