UnknownNot Applicable

Low Concentration Atropine in the Prevention of Myopia in Children.

China428 participantsStarted 2023-04-01

Plain-language summary

This double-blind, randomized controlled clinical study is to evaluate the effectiveness and safety of low concentration atropine in preventing myopia in pre-myopia children, and to explore whether there is a dose effect relationship between different concentrations of atropine in preventing myopia.

Who can participate

Age range

6 Years – 9 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. The age of the screening stage is 6-9 years, both sexes;
. 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;
. At least one of parents suffers from myopia (SE of at least one eye \<=-3.00D);
. Parents have signed informed consent and agree to participate in screening and follow-up.

Exclusion criteria

. Parents disagree to sign the informed consent;
. Presence of strabismus, amblyopia, or other ocular abnormalities, or have a history of eye surgery;
. Presence of other eye or systemic diseases;
. Allergies to low concentration atropine or sulfuric acid drugs;
. Histories of using other preventive measures, such as using red light within 6 months or atropine within 1 month;
. Presence of other situations that the researchers think is not appropriate for patients to be included in the project.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cumulative Incidence of Myopia

Timeframe: 1 year

Trial details

NCT IDNCT05939882

SponsorShanghai Eye Disease Prevention and Treatment Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04

Contact for this trial

Xiangui He

+8615000755422 xianhezi@163.com

View on ClinicalTrials.gov More Myopia, Progressive trials