UnknownNot Applicable

the Efficacy of 0.01% Atropine for Near Work-induced Transient Myopia and Myopic Progression

China150 participantsStarted 2023-10-01

Plain-language summary

Near work-induced transient myopia (NITM) is an important factor in permanent myopia (PM) development and progression. Atropine eye drop is beneficial in reducing initial NITM and slowing down myopic progression.Participants were randomly assigned in a 1:1 ratio to receive 0.01% atropine or placebo eye drop once nightly bilaterally for one year. Initial NITM, cycloplegic refraction, axial length (AL), best-corrected visual acuity (BCVA), intraocular pressure (IOP), and pupil diameter will be measured at baseline, 4-week, 12-week, 24-week, 36-week, and 48-week. Visual Function Questionnaire was administered at baseline and each follow-up visit. Adverse events also will be monitored and documented at each subsequent follow-up visit. This study investigates the efficacy of 0.01% atropine in the treatment of NITM and its possible association with the progression of refractive change in Chinese myopic children.

Who can participate

Age range

6 Years – 12 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: * Age 6 to 12 years * Subjects and their guardians agreed to participate in this study * Best-corrected visual acuity (BCVA) 0.1 (log minimum angle of resolution, LogMAR) or better. * Initial NITM (spherical equivalent) ≤ -0.25 D * Cycloplegic refractions ≥ -1.0 D and astigmatism ≤ 2.5 D in both eyes. * Anisometropia in both eyes ≤ 1.5 D Exclusion Criteria: * Children with existing systemic diseases including asthma, collagen disease, immune system disorders, prostate hypertrophy, spastic paralysis, Down's syndrome, severe cardiac, pulmonary, hepatic, and renal dysfunction. * Patients with glaucoma or high intraocular pressure, ocular inflammatory diseases, strabismus, amblyopia, corneal diseases, diseases of lens, retinal and optic neuropathy * Regular use of medications that may affect the efficacy of 0.01% atropine, including hairy fruit rutabaga eye drops, tropicamide eye drops, anticholinergic drugs such as pirenzepine and tropicamide, and cholinergic drugs such as carbachol and hairy fruit rutabaga. * Previous experiences with myopia control therapy. * A history of allergies to atropine. * Patients were deemed inappropriate for trial participation by the lead investigator.

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

Nearwork-induced transient myopia (NITM) in diopter

Timeframe: At baseline, week 4, week 12, week 24, week 36, and week 48

Trial details

NCT IDNCT06034366

SponsorHe Eye Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More Myopia trials