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

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05136950

Collaborator

(none)

228

Enrollment

Location

Arms

139.5

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lens Implantation, Intraocular	Procedure: Secondary in-the-bag IOL fixation Procedure: Secondary ciliary sulcus IOL fixation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

228 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 14, 2021

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Jul 30, 2033

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Secondary in-the-bag IOL fixation group

In-the-bag IOL fixation is the experimental arm

Procedure: Secondary in-the-bag IOL fixation

The experimental group with secondary IOL fixated in the capsular bag

Active Comparator: Secondary ciliary sulcus IOL fixation group

Ciliary sulcus IOL fixation is the control arm

Procedure: Secondary ciliary sulcus IOL fixation

The control group with secondary IOL fixated in the ciliary sulcus

Outcome Measures

Primary Outcome Measures

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

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
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
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
Intraocular lens tilt [Six months,one year, three years, five years, ten years after surgery]
Measured by anterior segment scanning
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 14 Years

Sexes Eligible for Study:

All

Accepts 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