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

Not Applicable

Completed

• Conditions: Postoperative Complications; Posterior Capsule Opacification
• Interventions: Procedure: cataract surgery; Procedure: Intraocular lens implantation

• Registration Number: NCT02491918
• Lead Sponsor: Iladevi Cataract and IOL Research Center

Brief 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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Study First Submitted: 2015-06-29
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-02
• Last Update Submitted: 2015-07-02
• Study First Posted: 2015-07-08
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optic Capture of IOL	cataract surgery	intraocular lens implantation in the capsular bag with posterior optic capture
Optic Capture of IOL	Intraocular lens implantation	intraocular lens implantation in the capsular bag with posterior optic capture
In the bag IOL	cataract surgery	Cataract surgery with IOL implantation in the capsular bag
In the bag IOL	Intraocular lens implantation	Cataract surgery with IOL implantation in the capsular bag

Primary Outcome Measures

Name	Time	Method
Posterior capsule opacification requiring surgery	12 months postoperatively	opacification of visual axis

Secondary Outcome Measures

Name	Time	Method
intraocular pressure in mmHg	12 months postoperatively	glaucoma
inflammation on slitlamp examination	12 months postoperatively	posterior synechiae