An interventional study of Atropine Eye drops in Pediatric Cataract, IOL Implantation and Myopia Progression, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 1 Year to 7 Years. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Cairo University · Not applicable, Interventional, and Prevention
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.
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.
165 studies on the registry are indexed under Intraocular Lymphoma; 9 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 113 interventional studies indexed under Intraocular Lymphoma.
Browse Intraocular Lymphoma studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion criteria:
Children receiving atropine 0.05% eye drops following IOL implantation. (as intervention)
Drug: Atropine Eye drops
Children receiving placebo eye drops following IOL implantation.
Atropine eye drops, 0.05%, will be given following IOL implantation for a period of 12 months.
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).
Time frame: 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).
Time frame: 12 months
Rate of side-effects of atropine 0.05% eye drop use.
Rate of side-effects of atropine 0.05 eye drops will be reported as mydriasis leading to photophobia, blurring, and local allergic responses.
Time frame: 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol
Start is estimated for Feb 2026; primary completion for Aug 2027, 18 months later.
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Studies of the drug tested here: Atropine