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

NCT07614113 | Completed

• 2 other identifiers: Sidra-2023-PhD-OP-003TUF/EIRB/ 237 /26
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Atropine; Bifocal Spectacles; Myopia Control; Children; Pakistan; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Mean Change in Spherical Equivalent Refraction (SER)

  Spherical equivalent refraction (SER) is calculated as sphere + (cylinder/2). Measurements are taken under cycloplegia achieved with 1% cyclopentolate or 1% tropicamide administered 30 minutes prior to measurement. An autorefractor is used to obtain three consecutive readings per eye; the mean value is used for analysis. SER is measured in diopters (D). A negative change indicates myopia progression (increase in myopia).

  Baseline and 12 months

Secondary Outcomes (2)

• Mean Change in Axial Length

  Baseline and 12 months

• Number of Participants with Treatment-Emergent Adverse Events

  Up to 12 months

Study Arms (2)

Atropine 0.05% Monotherapy

ACTIVE COMPARATOR

Participants receive atropine sulfate 0.05% ophthalmic solution, one drop in each eye once daily at bedtime, for 12 months.

Drug: Atropine Sulfate 0.05% Ophthalmic Solution

Combination Therapy (Atropine 0.05% + Bifocal Spectacles)

EXPERIMENTAL

Participants receive atropine sulfate 0.05% ophthalmic solution (same regimen as Arm A) PLUS bifocal spectacle correction with distance correction based on cycloplegic refraction and +2.00 D near addition. Spectacles are to be worn during all waking hours.

Device: Bifocal Spectacles

Interventions

Atropine Sulfate 0.05% Ophthalmic Solution DRUG

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).

Atropine 0.05% Monotherapy

Bifocal Spectacles DEVICE

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.

Combination Therapy (Atropine 0.05% + Bifocal Spectacles)

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (1)

The University of Faisalabad

Faisalābad, Punjab Province, 3800, Pakistan

Location

MeSH Terms

Conditions

Myopia; Myopia, Degenerative; Refractive Errors

Interventions

Atropine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 29, 2026
• Study Start: February 17, 2025
• Primary Completion: April 30, 2026
• Study Completion: May 15, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)