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

January 6, 2022 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Guangzhou, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou, China, 510060
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of glaucoma-related adverse events
Time Frame: One year after surgery
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
Time Frame: 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
Six months,three years, five years, ten years after surgery
Visual acuity
Time Frame: 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
Six months,one year, three years, five years, ten years after surgery
Ocular refractive power
Time Frame: Six months,one year,three years, five years, ten years after surgery
Measured by the Auto Refractometer
Six months,one year,three years, five years, ten years after surgery
Intraocular lens decentration
Time Frame: Six months,one year, three years, five years, ten years after surgery
Measured by anterior segment scanning
Six months,one year, three years, five years, ten years after surgery
Intraocular lens tilt
Time Frame: Six months,one year, three years, five years, ten years after surgery
Measured by anterior segment scanning
Six months,one year, three years, five years, ten years after surgery
Incidence of other adverse events
Time Frame: 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
Six months,one year, three years, five years, ten years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

  • Principal Investigator: Yizhi Liu, PhD, Zhongshan Ophthalmic center, Guangzhou, People's Republic of China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2021

Primary Completion (Anticipated)

July 30, 2023

Study Completion (Anticipated)

July 30, 2033

Study Registration Dates

First Submitted

November 1, 2021

First Submitted That Met QC Criteria

November 15, 2021

First Posted (Actual)

November 30, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021KYPJ135

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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