Efficacy of Topical Atropine Eye Drops for Control of Myopia Progression Among Children Attending Mansoura University Ophthalmic Center

Sponsor
Mansoura University
Study ID
NCT07164092
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Atropine 0.05% Eye drops — DRUG
    The randomized eye will receive one drop of atropine sulphate 0.05% nightly for 24 months.
  • Placebo ophthalmic solution — DRUG
    The fellow eye will receive one drop of placebo (vehicle solution without active drug) nightly for 24 months.

Study Details

This randomized controlled trial aims to evaluate the efficacy and safety of low-dose topical atropine sulphate (0.05%), a non-selective muscarinic antagonist, in slowing the progression of myopia and ocular axial elongation in children. The study will be conducted at Mansoura Ophthalmic Center, Mansoura University, Egypt, from October 2025 to october 2027. Eligible participants are myopic children attending the outpatient clinic during the study period. Participants will be stratified into three groups according to baseline myopia severity (low, moderate, and high). Each child will be randomized to receive one drop of atropine 0.05% in one eye and one drop of placebo in the fellow eye nightly for 24 months. The allocation of treatment to right or left eye will be randomized to avoid laterality bias. Study Outcomes * Primary Outcome o Change in ocular axial length (AL) from baseline to 24 months, measured with a NIDEK AL-scan optical biometer (average of five readings within a deviation of ≤0.05 mm). This parameter was used for sample size estimation. * Secondary Outcomes * Change in spherical equivalent refraction (SER), measured by cycloplegic autorefraction using a Topcon KR-800 autorefractor after standard cycloplegia with cyclopentolate 1%. * Best-corrected distance visual acuity (BCVA). * Sample Size The primary endpoint of this trial is the change in ocular axial length (AL) over 24 months, analyzed as a paired comparison between the atropine-treated and placebo-treated eyes within each child. Sample size estimation was based on previously published data reporting mean axial elongation of 0.115 ± 0.11 mm in atropine-treated eyes compared with 0.303 ± 0.12 mm in placebo-treated eyes, yielding a mean difference of 0.188 mm. Assuming an inter-eye correlation of 0.6, the standard deviation of the paired difference is estimated at approximately 0.10 mm, giving an effect size of d = 1.88. Using a two-tailed paired t-test with α = 0.05 and 90% power, the minimum required sample size is 12 children.

Key Dates

First listed
Sep 9, 2025
Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Atropine 0.05% Eye
    The randomized eye will receive one drop of atropine sulphate 0.05% nightly for 24 months.
  • Placebo Comparator: Placebo Eye
    The fellow eye will receive one drop of placebo (vehicle solution without active drug) nightly for 24 months.

Primary Outcome Measure

Change in ocular axial length (AL) [ Time Frame: 2 years ]

Central Contacts

Related Studies