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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-14

Study Completion Date

2033-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Glaucoma Following Pediatric Cataract Surgery

NCT05451745

Glaucoma Following Pediatric Cataract Surgery Glaucoma Secondary Congenital Cataract

ACTIVE_NOT_RECRUITING

Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma

NCT05892185

Glaucoma

UNKNOWN NA

AGV Implantation With Ologen in Pediatric Glaucomas

NCT05014386

Glaucoma

UNKNOWN NA

Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma

NCT03610295

Congenital Cataract Aphakic Glaucoma

COMPLETED NA

Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma

NCT05797350

Glaucoma

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lens Implantation, Intraocular

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Secondary in-the-bag IOL fixation group

In-the-bag IOL fixation is the experimental arm

Group Type EXPERIMENTAL

Secondary in-the-bag IOL fixation

Intervention Type PROCEDURE

The experimental group with secondary IOL fixated in the capsular bag

Secondary ciliary sulcus IOL fixation group

Ciliary sulcus IOL fixation is the control arm

Group Type ACTIVE_COMPARATOR

Secondary ciliary sulcus IOL fixation

Intervention Type PROCEDURE

The control group with secondary IOL fixated in the ciliary sulcus

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Secondary in-the-bag IOL fixation

The experimental group with secondary IOL fixated in the capsular bag

Intervention Type PROCEDURE

Secondary ciliary sulcus IOL fixation

The control group with secondary IOL fixated in the ciliary sulcus

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Months

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No