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

Not Applicable

Recruiting

• Conditions: Lens Implantation, Intraocular
• Interventions: Procedure: Secondary in-the-bag IOL fixation; Procedure: Secondary ciliary sulcus IOL fixation

• Registration Number: NCT05136950
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-30
• Study Start: 2021-12-14
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-11
• Primary Completion: 2023-07-30
• Study Completion: 2033-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 228

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Secondary in-the-bag IOL fixation group	Secondary in-the-bag IOL fixation	In-the-bag IOL fixation is the experimental arm
Secondary ciliary sulcus IOL fixation group	Secondary ciliary sulcus IOL fixation	Ciliary sulcus IOL fixation is the control arm

Primary Outcome Measures

Name	Time	Method
Incidence of glaucoma-related adverse events	One year after surgery	The assessment of glaucoma-related adverse events is performed at one year after surgery

Secondary Outcome Measures

Name	Time	Method
Incidence of glaucoma-related adverse events	Six months,three years, five years, ten years after surgery	The assessment of glaucoma-related AEs is performed at six months, three years, five years, ten years after surgery
Incidence of other adverse events	Six months,one year, three years, five years, ten years after surgery	The assessment of other adverse events will be performed at six months,one year,three years, five years, ten years after surgery
Visual acuity	Six months,one year, three years, five years, ten years after surgery	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
Intraocular lens tilt	Six months,one year, three years, five years, ten years after surgery	Measured by anterior segment scanning
Ocular refractive power	Six months,one year,three years, five years, ten years after surgery	Measured by the Auto Refractometer
Intraocular lens decentration	Six months,one year, three years, five years, ten years after surgery	Measured by anterior segment scanning

Trial Locations

Locations (1)

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