About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children after IOL implantation (primary or secondary)
Age 1-7 years
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Atropine Eye drops
DrugAtropine eye drops, 0.05%, will be given following IOL implantation for a period of 12 months.
Treatment groups
Trial outcomes
Primary outcomes
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).
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).
Secondary outcomes
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.
Sponsors and contacts
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