Comparing glaucoma risks in children after different types of lens implantation
Official title: Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation, In-the-bag Versus Sulcus Fixation : a Randomized Controlled Trial
Run by Zhongshan Ophthalmic Center, Sun Yat-sen University · NCT05136950 · Data updated 2026-11-12
This study is testing which type of lens surgery for children with congenital cataracts leads to fewer glaucoma-related problems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Months to 14 Years |
| Sex | All |
| Enrollment | 228 (estimated) |
| Sponsor | Zhongshan Ophthalmic Center, Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou) |
| Status | Recruiting |
| Started | December 14, 2021 |
| Main results expected | July 30, 2023 |
| Study ends | July 30, 2033 |
| Registry record updated | January 11, 2022 |
| Trial ID | NCT05136950 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged between 18 months and 14 years who have a primary diagnosis of congenital cataract and have undergone cataract extraction at a young age.
✕Probably not a fit
Patients who have had primary IOL implantation or pre-existing ocular diseases that could affect the outcomes of the secondary IOL implantation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the incidence of glaucoma-related adverse events in pediatric patients undergoing secondary intraocular lens (IOL) implantation. It compares two methods: in-the-bag IOL fixation and ciliary-sulcus-fixed IOL implantation, specifically in children diagnosed with congenital cataracts. The research focuses on children aged 18 months to 14 years who have undergone cataract extraction at a young age. By analyzing the outcomes of these two techniques, the study seeks to identify which method may lead to fewer complications related to glaucoma.
Why it matters
Potential benefit: If successful, this study could help determine safer lens implantation techniques for children, potentially reducing the risk of glaucoma-related complications.
How similar studies have gone: While the specific comparison of these two IOL fixation methods in pediatric patients is less common, previous studies have indicated varying success rates and complications associated with different IOL implantation techniques.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou, China, 510060
Guangzhou, China Recruiting
Study contacts
- Principal investigator: Yizhi Liu, PhD — Zhongshan Ophthalmic center, Guangzhou, People's Republic of China
- Study coordinator: Zhenzhen Liu, PhD
- Email: liu_zhenzhen@qq.com
- Phone: +86 13570382241
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.