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Atropine Alone vs Atropine Plus Bifocal Spectacles for Myopia Control in Children

NCT07614113 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-05-29

No results posted yet for this study

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.

Conditions

  • Myopia
  • Progressive Myopia
  • Refractive Errors

Interventions

DRUG

Atropine Sulfate 0.05% Ophthalmic Solution

Atropine sulfate 0.05% ophthalmic solution. One drop instilled in each eye once daily at bedtime. Parents or guardians are trained in proper instillation technique. Compliance is monitored by counting returned empty bottles at each follow-up visit (3, 6, 9, and 12 months).

DEVICE

Bifocal Spectacles

Bifocal spectacle correction prescribed based on cycloplegic refraction for distance correction with a near addition of +2.00 Diopters. Spectacles are to be worn during all waking hours. Compliance is assessed through parental interview and observation at each follow-up visit.

Sponsors & Collaborators

  • University of Faisalabad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-17
Primary Completion
2026-04-30
Completion
2026-05-15

Countries

  • Pakistan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07614113 on ClinicalTrials.gov