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

Zhongshan Ophthalmic Center, Sun Yat-sen University228 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

228

Conditions

Lens Implantation, Intraocular

Interventions

Secondary in-the-bag IOL fixationPROCEDURE

The experimental group with secondary IOL fixated in the capsular bag

Secondary ciliary sulcus IOL fixationPROCEDURE

The control group with secondary IOL fixated in the ciliary sulcus

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 14 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou, China, 510060

Guangzhou, China

RECRUITING

Outcomes

Primary Outcomes

Incidence of glaucoma-related adverse events

The assessment of glaucoma-related adverse events is performed at one year after surgery

Time frame: One year after surgery

Secondary Outcomes

Incidence of glaucoma-related adverse events

The assessment of glaucoma-related AEs is performed at six months, three years, five years, ten years after surgery

Time frame: Six months,three years, five years, ten years after surgery

Visual acuity

Evaluated with an ETDRS chart. For those who are unable to use ETDRS chart, visual acuity will be evaluated with Lea Symbol Chart or Teller Acuity Cards

Time frame: Six months,one year, three years, five years, ten years after surgery

Ocular refractive power

Measured by the Auto Refractometer

Time frame: Six months,one year,three years, five years, ten years after surgery

Intraocular lens decentration

Measured by anterior segment scanning

Time frame: Six months,one year, three years, five years, ten years after surgery

Intraocular lens tilt

Measured by anterior segment scanning

Time frame: Six months,one year, three years, five years, ten years after surgery

Incidence of other adverse events

The assessment of other adverse events will be performed at six months,one year,three years, five years, ten years after surgery

Time frame: Six months,one year, three years, five years, ten years after surgery

Central Contacts

Zhenzhen Liu, PhD

CONTACT

+86 13570382241 liu_zhenzhen@qq.com

Data from ClinicalTrials.gov

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