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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07364370
Enrollment
50
Registered
2026-01-23
Start date
2026-02-01
Completion date
2027-12-01
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IOL Implantation, Myopia Progression, Pediatric Cataract

Keywords

pediatric cataract, iol, iol implantation, myopia

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.

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.

Interventions

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in spherical equivalent in diopters of each group.Over a period of 12 monthsSpherical equivalent will be determined using auto-refractometer and/or manual retinoscopy. It will be reported in diopters (D).
Change in axial length in millimeters in each group.12 monthsAxial length will be measured using A-scan or optical biometry and will be reported in millimeters (mm).

Secondary

MeasureTime frameDescription
Rate of side-effects of atropine 0.05% eye drop use.12 monthsRate of side-effects of atropine 0.05 eye drops will be reported as mydriasis leading to photophobia, blurring, and local allergic responses.

Countries

Egypt

Contacts

CONTACTRawan Hosny, MSc
rawan.m.hosny@students.kasralainy.edu.eg+201005556839

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026