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

NCT07364370 | Not Yet Recruiting

• 1 other identifier: MD-433-2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Cataract; IOL Implantation; Myopia Progression

Keywords

pediatric cataract; iol; iol implantation; myopia

Outcome Measures

Primary Outcomes (2)

• Change in spherical equivalent in diopters of each group.

  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.

  Axial length will be measured using A-scan or optical biometry and will be reported in millimeters (mm).

  12 months

Secondary Outcomes (1)

• Rate of side-effects of atropine 0.05% eye drop use.

  12 months

Study Arms (2)

Atropine

EXPERIMENTAL

Children receiving atropine 0.05% eye drops following IOL implantation. (as intervention)

Drug: Atropine Eye drops

Control

NO INTERVENTION

Children receiving placebo eye drops following IOL implantation.

Interventions

Atropine Eye drops DRUG

Atropine eye drops, 0.05%, will be given following IOL implantation for a period of 12 months.

Atropine

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11965, Egypt

Location

MeSH Terms

Conditions

Intraocular Lymphoma; Myopia

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Eye Neoplasms; Neoplasms by Site; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Refractive Errors; Eye Diseases

Central Study Contacts

Rawan Hosny, MSc

CONTACT

+201005556839; rawan.m.hosny@students.kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology at Cairo University

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 23, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)