Ireland
--:--IST
Recruiting Not applicable

Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation

NCT05136950 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2021-12-14
Last updated
2022-01-11

Condition(s) studied

Lens Implantation, Intraocular

Investigational drug(s) / intervention(s)

Secondary in-the-bag IOL fixationSecondary ciliary sulcus IOL fixation

Secondary in-the-bag IOL fixation: The experimental group with secondary IOL fixated in the capsular bag

Secondary ciliary sulcus IOL fixation: The control group with secondary IOL fixated in the ciliary sulcus

Study summary

To compare the incidence of glaucoma-related adverse events of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (IOL) implantation in pediatric aphakia

Eligibility

Sex
ALL
Min age
18 Months
Max age
14 Years
Healthy volunteers
No
Inclusion Criteria: * Aged between 18 months and 14 years * Had a primary diagnosis of congenital cataract. * Underwent cataract extraction between the ages of 2 and 24 months Exclusion Criteria: * Primary IOL implantation * Pre-existing ocular disease which might affect the location and outcome of secondary IOL implantation (including and not restricted to microphthalmia, microcornea, microcornea, corneal opacity, pseudopterygium, iris anomaly, glaucoma diagnosed before cataract extraction, uveitis, persistent fetal vasculature or trauma) * Suture fixation for secondary IOL implantation

Primary outcome measure(s)

  • Incidence of glaucoma-related adverse events — One year after surgery
    The assessment of glaucoma-related adverse events is performed at one year after surgery

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou, China, 510060 Guangzhou China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05136950 on ClinicalTrials.gov ↗ ← All trials in China