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

NCT ID: NCT07164092

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-09-30

Brief Summary

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Atropine 0.05% Eye

The randomized eye will receive one drop of atropine sulphate 0.05% nightly for 24 months.

Group Type: EXPERIMENTAL

Atropine 0.05% Eye drops

Intervention Type: DRUG

The randomized eye will receive one drop of atropine sulphate 0.05% nightly for 24 months.

Placebo Eye

The fellow eye will receive one drop of placebo (vehicle solution without active drug) nightly for 24 months.

Group Type: PLACEBO_COMPARATOR

Placebo ophthalmic solution

Intervention Type: DRUG

The fellow eye will receive one drop of placebo (vehicle solution without active drug) nightly for 24 months.

Interventions

Atropine 0.05% Eye drops

The randomized eye will receive one drop of atropine sulphate 0.05% nightly for 24 months.

Intervention Type: DRUG

Placebo ophthalmic solution

The fellow eye will receive one drop of placebo (vehicle solution without active drug) nightly for 24 months.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Myopia of at least -1.0 D in both eyes, astigmatism of less than 2.0 D, anisometropia of objective spherical equivalent ≤ 1.50 D.
• Documented myopic progression of at least 0.5 D in the past one year.

Exclusion Criteria

• Children with ocular or systemic diseases that potentially influence myopia or refractive power.
• Ocular diseases, e.g., cataracts, glaucoma
• Posterior segment hereditary and acquired pathological disorders.
• History of any previous ocular surgery.
• History of any ocular injuries.
• Previous use of interventions (such as atropine, pirenzepine, orthokeratology lens, or other optical methods) for myopia control
• Allergy to atropine, cyclopentolate or benzalkonium chloride

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Allam

Lecturer of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ghada H. Allam, Dr

Role: CONTACT

drghada_allam@mans.edu.eg

+201062838323

Other Identifiers

Atropine ED for Myopia in MOC

Identifier Type: -

Identifier Source: org_study_id