Myopia Progression Control Using Atropine 0.05% After Pediatric Cataract Surgery And Intraocular Lens Implantation Surgery

January 15, 2026 updated by: Ahmed Awadein, Cairo University

Myopia Progression Control Using Atropine 0.05% After Pediatric Cataract Surgery And Intraocular Lens Implantation Surgery: A Randomized Clinical Trial

Myopic shift remains a debilitating and unpredictable adverse event following pediatric cataract surgery. While research exploring peripheral myopic defocus for post-cataract surgery myopia prevention shows promising results, the use of multifocal intra-ocular lenses (IOLs) cannot be used liberally in countries with high disease burden and challenged economies due to high price and decreased availability. To date there are no studies evaluating the use of topical atropine for the management of myopic shift following pediatric cataract surgery.

The investigators aim to explore the use of 0.05% topical atropine in the prevention and management of myopic shift following pediatric cataract surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cataract is a leading cause of visual impairment in the pediatric age group, with an annual incidence of 1.8 to 3.6 per 10,000. The visual morbidity is not only due to media opacity caused by the cataracts, but also secondary to long lasting effects following cataract extraction, with timing and biometric aim of IOL implantation procedure presenting a unique challenge.

Normal ocular growth is characterized by axial length elongation along with corneal and lenticular flattening with a net refractive shift of approximately -0.9D. Cataract surgery in infants interrupts normal emmetropization of eyes and can lead to large myopic shift which may reach over 10 D.

Myopia is an epidemic with an estimated increase in prevalence to 50% by 2025. Rapidly progressing myopia significantly increases risk of permanent visual loss due to several ocular complications as maculopathy, retinal detachment and glaucoma.

Strategies for myopia control and prevention involve both optical and pharmacological measures, with atropine being a cornerstone in myopia management. Initially, it was believed that atropine limits myopia progression via blocking accommodation. Recently, however, it has been shown that atropine functions via a non-accommodative pathway. It is hypothesized that atropine exerts its action via regulation of dopamine release in retinal amacrine cells, which leads to reduction of rate of axial growth of eye. Another plausible mechanism is that up- and down-regulation of scleral muscarinic receptors influences scleral matrix deposition. Multiple low-dose concentrations have been studied, with older age and lower grades of myopia showing better response. Younger age requires the highest available concentration (0.05) to achieve adequate response.

While research exploring peripheral myopic defocus for post-cataract surgery myopia prevention shows promising results, the use of multifocal IOLs cannot be used liberally in countries with high disease burden and challenged economies due to high price and decreased availability. To date there are no studies evaluating the use of topical atropine for the management of myopic shift following pediatric cataract surgery.

The investigators aim to explore the use of 0.05% topical atropine in the prevention and management of myopic shift following pediatric cataract surgery.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Children after IOL implantation (primary or secondary)
  2. Age 1-7 years

Exclusion criteria:

  1. Eyes with post-operative media opacity hindering adequate assessment of refraction
  2. Eyes with complicated surgeries (e.g. vitreous loss, dropped lens matter requiring PPV, retinal detachment, etc)
  3. Retinal pathologies
  4. Glaucoma (congenital or secondary to surgery)
  5. Anterior or posterior segment anomalies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atropine
Children receiving atropine 0.05% eye drops following IOL implantation. (as intervention)
Drug: Atropine Eye drops
Atropine eye drops, 0.05%, will be given following IOL implantation for a period of 12 months.
No Intervention: Control
Children receiving placebo eye drops following IOL implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in spherical equivalent in diopters of each group.
Time Frame: Over a period of 12 months
Spherical equivalent will be determined using auto-refractometer and/or manual retinoscopy. It will be reported in diopters (D).
Over a period of 12 months
Change in axial length in millimeters in each group.
Time Frame: 12 months
Axial length will be measured using A-scan or optical biometry and will be reported in millimeters (mm).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of side-effects of atropine 0.05% eye drop use.
Time Frame: 12 months
Rate of side-effects of atropine 0.05 eye drops will be reported as mydriasis leading to photophobia, blurring, and local allergic responses.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-433-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication will be available upon request to rawan.m.hosny@students.kasralainy.edu.eg with strict patient anonymity ensured.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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