Atropine Alone vs Atropine Plus Bifocal Spectacles for Myopia Control in Children (NCT07614113) | Clinical Trial Compass
CompletedNot Applicable
Atropine Alone vs Atropine Plus Bifocal Spectacles for Myopia Control in Children
Pakistan210 participantsStarted 2025-02-17
Plain-language summary
Background: Myopia (nearsightedness) is a growing global health concern, projected to affect 50% of the world population by 2050. Children with progressive myopia are at risk of serious ocular complications including myopic maculopathy, glaucoma, and retinal detachment. Low-dose atropine (0.05%) has shown efficacy in slowing myopia progression, and optical interventions such as bifocal spectacles may provide additional benefits by altering peripheral retinal defocus. Objective: This randomized controlled trial aims to compare the efficacy and effectiveness of atropine 0.05% monotherapy versus combination therapy (atropine 0.05% plus bifocal spectacles) in controlling myopia progression in children. Methods: Children aged 4-16 years with bilateral myopia (cycloplegic spherical equivalent between -1.00 D and -6.00 D) and documented recent progression (≥ -0.50 D in the preceding 12 months) will be randomized 1:1 to receive either atropine 0.05% eye drops once daily or atropine 0.05% plus bifocal spectacles. The primary outcome is change in spherical equivalent refraction over 12 months; the secondary outcome is change in axial length. Follow-up visits occur at 3, 6, 9, and 12 months. Conclusion: This study will provide evidence on whether adding bifocal correction to pharmacological therapy offers superior myopia control compared to atropine alone, informing clinical practice guidelines for pediatric myopia management.
Who can participate
Age range
4 Years – 16 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:
* Children aged 4 to 16 years
* Bilateral myopia with cycloplegic spherical equivalent refraction between -1.00 D and -6.00 D in each eye
* Documented recent myopia progression of ≥ -0.50 D over the preceding 12 months
* Best-corrected visual acuity (BCVA) of at least 6/12 (Snellen) or equivalent in each eye
* Parent or guardian able and willing to provide written informed consent
* Child assent when applicable (age 7 years and above per institutional policy)
Exclusion Criteria:
* Ocular conditions affecting myopia progression: strabismus, amblyopia, significant astigmatism (\>2.50 D), anisometropia (\>2.50 D), cataract, glaucoma, uveitis, or history of ocular surgery
* Prior myopia-control treatment within 6 months (atropine, orthokeratology, multifocal contact lenses, pirenzepine)
* Known allergy or hypersensitivity to atropine or spectacle materials
* Systemic or neurodevelopmental disorders affecting cooperation or refractive development
* Inability to obtain accurate axial length or cycloplegic refraction measurements
* Parent or guardian refusal to provide informed consent
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
1
Mean Change in Spherical Equivalent Refraction (SER)