NCT07364370

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 1 Year – 7 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pediatric Cataract
• IOL Implantation
• Myopia Progression

Interventions

Type	Name	Description
DRUG	Atropine Eye drops	Atropine eye drops, 0.05%, will be given following IOL implantation for a period of 12 months.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-08-01
• Completion: 2027-12-01
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: Egypt