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

Sun Yat-sen University

Status: Enrolling

Conditions: Lens Implantation, Intraocular

Treatments: Procedure: Secondary ciliary sulcus IOL fixation; Procedure: Secondary in-the-bag IOL fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT05136950

2021KYPJ135

Details and patient eligibility

About

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

Full 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.

Enrollment: 228 estimated patients

Sex: All

Ages: 18 months to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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228 participants in 2 patient groups

Secondary in-the-bag IOL fixation group

Experimental group

Description:

In-the-bag IOL fixation is the experimental arm

Treatment:

Procedure: Secondary in-the-bag IOL fixation

Secondary ciliary sulcus IOL fixation group

Active Comparator group

Description:

Ciliary sulcus IOL fixation is the control arm

Treatment:

Procedure: Secondary ciliary sulcus IOL fixation