0.01% atropine eye drops to slow eye growth and prescription changes in myopic children
Official title: The Effect of 0.01% Atropine Eye Drops on Axial Length and Refraction in Myopic Children Compared to a Control Group
Run by Liaquat National Hospital & Medical College · NCT07456488 · Data updated 2026-11-12
This will try nightly 0.01% atropine eye drops for six months in children aged 4–16 with myopia to see if it slows axial eye growth and refractive worsening compared with a control group.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 4 Years to 16 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Liaquat National Hospital & Medical College Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Status | Recruiting |
| Started | July 13, 2025 |
| Main results expected | April 17, 2026 |
| Study ends | April 30, 2026 |
| Registry record updated | March 6, 2026 |
| Trial ID | NCT07456488 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 4–16 with at least −1.00 D of myopia, astigmatism ≤2.50 D, good corrected visual acuity, no prior atropine or other myopia treatments, and no systemic or ocular conditions that predispose to severe myopia.
✕Probably not a fit
Children with high astigmatism (≥2.5 D), significant anisometropia (>1 D), prior intraocular surgery, prior atropine use, allergy to atropine, or systemic/syndromic causes of myopia are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional study gives myopic children 0.01% atropine eye drops once nightly for six months and compares axial length and refraction changes to a control group. Eligible participants are children aged 4–16 with at least −1.00 D of spherical equivalent myopia and limited astigmatism, with key ocular and systemic exclusions. Axial length and refractive error will be measured at baseline and follow-up visits to quantify change, and safety/tolerability will be monitored. The study is conducted at a single center with standard ophthalmic measurement protocols.
Why it matters
Potential benefit: If successful, nightly low-dose atropine could slow axial elongation and reduce worsening of prescription in children with myopia, potentially lowering future vision problems.
How similar studies have gone: Other clinical studies of low‑dose atropine (including 0.01%) have shown modest slowing of myopia progression with good tolerability, though some later trials suggest higher low doses may achieve greater effect.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged 4-16 years * Both genders * Myopia of baseline SER of -1.00D or more * Astigmatism less than or equal to -2.50D * No medical history predisposing severe myopia (e.g., Marfan syndrome, Stickler syndrome, and retinopathy of prematurity), abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, and spherophakia) * No history of other vision-threatening ocular diseases or previous intraocular surgery. * No current or previous use of atropine or pirenzipine, contact lenses or other forms of treatment that may affect myopia progression. Exclusion Criteria: * Astigmatism ≥ 2.5 D * Anisometropia\>1 D * Best corrected visual acuity \< 0.5 (6/12) * Prior intraocular surgery * Allergy to atropine eye drops * Systemic diseases associated with myopia such as Marfan syndrome, Stickler syndrome * History of cardiac or significant respiratory diseases * Lack of consent for participating in the study
Where it's running
-
LiaquatNHMC
Karachi, Sindh, Pakistan Recruiting
Study contacts
- Principal investigator: Hina Nadeem, MBBS — Lnhmc
- Study coordinator: Hina Nadeem, MBBS
- Email: hinanadeem1508@gmail.com
- Phone: 03252120568
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.