NCT02491918

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

Visual Axis Obscuration and Postoperative Complications Following Pediatric Cataract Surgery With Introacular Lens Implantation In-the-bag Versus Posterior Optic Capture : A Randomized, Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Iladevi Cataract and IOL Research Center · Academic / Other
• Sex: All
• Age: 15 Days – 4 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Posterior Capsule Opacification
• Postoperative Complications

Interventions

Type	Name	Description
PROCEDURE	cataract surgery	cataract surgery in children
PROCEDURE	Intraocular lens implantation	intraocular lens implantation in the capsular bag or optic capture

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2015-07-08
• Last updated: 2015-07-08