Clinical Trial : Complications of in the Bag IOL Versus Optic Capture of IOL in Pediatric Cataract Surgery

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

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-04-30

Brief Summary

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

This prospective, randomized, clinical trial looks to compare children undergoing congenital cataract surgery with intraocular lens (IOL) implantation in terms of visual axis obscuration as well as postoperative complications such as glaucoma, inflammation and IOL centration when IOL fixation is performed using two different techniques : 1) conventional in the bag IOL implantation with anterior vitrectomy, and, 2) posterior optic capture of the IOL through the posterior capsulorhexis without any vitrectomy. 61 eyes of 61 children randomized to receiving IOL implantation using one of the two techniques will be followed up until 12 months postoperatively.

Related Clinical Trials

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

Contrast Sensitivity Assessment in Pediatric Cataract Surgery With IOL Implantation

NCT01901744

Contrast Sensitivity

COMPLETED NA

Aphakia Versus Pseudophakia in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery

NCT01297153

Congenital Cataract

COMPLETED PHASE4

Corneal Endothelial Changes Following Pediatric Cataract Surgery With IOL Implantation

NCT01504607

Congenital Cataract Surgery IOL Implantation Change in Corneal Endothelial Cell Morphology

COMPLETED

Optic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery

NCT05461040

Cataract, Juvenile

COMPLETED NA

Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification

NCT01664689

Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery

COMPLETED NA

Detailed Description

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

This prospective, randomized, controlled, clinical trial compares visual axis obscuration as well as intra and postoperative complications in children undergoing cataract surgery with IOL implantation using one of two techniques :

1. in the bag IOL with limbal anterior vitrectomy
2. posterior optic capture of IOL optic through the posterior capsulorhexis without any vitrectomy.

The aim is to evaluate whether avoiding anterior vitrectomy is a feasible option, particularly younger children, where anterior vitrectomy has become an integral part of the routine surgical strategy.

All children will be evaluated at 1 month, 3 months, 6 months and 12 months postoperatively.

Conditions

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

Posterior Capsule Opacification Postoperative Complications

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

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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

In the bag IOL

Cataract surgery with IOL implantation in the capsular bag

Group Type ACTIVE_COMPARATOR

cataract surgery

Intervention Type PROCEDURE

cataract surgery in children

Intraocular lens implantation

Intervention Type PROCEDURE

intraocular lens implantation in the capsular bag or optic capture

Optic Capture of IOL

intraocular lens implantation in the capsular bag with posterior optic capture

Group Type ACTIVE_COMPARATOR

cataract surgery

Intervention Type PROCEDURE

cataract surgery in children

Intraocular lens implantation

Intervention Type PROCEDURE

intraocular lens implantation in the capsular bag or optic capture

Interventions

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

cataract surgery

cataract surgery in children

Intervention Type PROCEDURE

Intraocular lens implantation

intraocular lens implantation in the capsular bag or optic capture

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* uncomplicated cataract,
* unilateral or bilateral cataract,
* corneal diameter \>9.0mmHg

Exclusion Criteria

* pre-existing glaucoma,
* uveitis,
* ocular comorbidity,
* microphthalmos,
* microcornea,
* parents not consenting to participate in study,
* traumatic cataract

Minimum Eligible Age

15 Days

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No