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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Posterior Capsule Opacification
• Intervention / Treatment: Procedure: cataract surgery; Procedure: Intraocular lens implantation

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 4 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: In the bag IOL; Cataract surgery with IOL implantation in the capsular bag	Procedure: cataract surgery; cataract surgery in children; Procedure: Intraocular lens implantation; intraocular lens implantation in the capsular bag or optic capture
Active Comparator: Optic Capture of IOL; intraocular lens implantation in the capsular bag with posterior optic capture	Procedure: cataract surgery; cataract surgery in children; Procedure: Intraocular lens implantation; intraocular lens implantation in the capsular bag or optic capture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posterior capsule opacification requiring surgery	opacification of visual axis	12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammation on slitlamp examination	cell depostis	12 months postoperatively
inflammation on slitlamp examination	posterior synechiae	12 months postoperatively
intraocular pressure in mmHg	glaucoma	12 months postoperatively

Collaborators and Investigators

• Sponsor: Iladevi Cataract and IOL Research Center
• Investigators: Study Director: abhay vasavada, MS,FRCS, Iladevi Cataract & IOL Research Centre, Ahmedabad, India

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: July 2, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Estimate): July 8, 2015
• Last Update Submitted That Met QC Criteria: July 2, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Cataract; Postoperative Complications; Capsule Opacification
• Other Study ID Numbers: 13-009; 2013 Research Foundation Grant (Other Grant/Funding Number: ASCRS Foundation Research Grant)