NCT05136950

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

Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation, In-the-bag Versus Sulcus Fixation : a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Months – 14 Years
• Healthy volunteers: Not accepted

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

Detailed description

Treatment of pediatric cataract, one of the leading causes of childhood blindness globally, remains challenging because of extremely high incidence of glaucoma-related adverse events (AEs) after IOL implantation. The investigators aim to compare the incidence of glaucoma-related AEs of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (IOL) implantation in pediatric aphakia.

Conditions

• Lens Implantation, Intraocular

Interventions

Type	Name	Description
PROCEDURE	Secondary in-the-bag IOL fixation	The experimental group with secondary IOL fixated in the capsular bag
PROCEDURE	Secondary ciliary sulcus IOL fixation	The control group with secondary IOL fixated in the ciliary sulcus

Timeline

• Start date: 2021-12-14
• Primary completion: 2023-07-30
• Completion: 2033-07-30
• First posted: 2021-11-30
• Last updated: 2022-01-11

Locations

1 site across 1 country: China