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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lens Implantation, Intraocular

Intervention / Treatment
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* Procedure: Secondary in-the-bag IOL fixation
* Procedure: Secondary ciliary sulcus IOL fixation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secondary in-the-bag IOL fixation group<br>In-the-bag IOL fixation is the experimental arm | Procedure: Secondary in-the-bag IOL fixation<br>* The experimental group with secondary IOL fixated in the capsular bag<br>|
| Active Comparator: Secondary ciliary sulcus IOL fixation group<br>Ciliary sulcus IOL fixation is the control arm | Procedure: Secondary ciliary sulcus IOL fixation<br>* The control group with secondary IOL fixated in the ciliary sulcus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of glaucoma-related adverse events | The assessment of glaucoma-related adverse events is performed at one year after surgery | One year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Six months,one year, three years, five years, ten years after surgery | 
| Ocular refractive power | Measured by the Auto Refractometer | Six months,one year,three years, five years, ten years after surgery | 
| Intraocular lens decentration | Measured by anterior segment scanning | Six months,one year, three years, five years, ten years after surgery | 
| Intraocular lens tilt | Measured by anterior segment scanning | 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 | Six months,one year, three years, five years, ten years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric aphakia, Secondary Intraocular Lens Implantation, Glaucoma-related Adverse Events, In-the-bag IOL implantation, Sulcus IOL fixation