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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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 Summary:

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.


Sponsor: Iladevi Cataract and IOL Research Center

Current Primary Outcome: Posterior capsule opacification requiring surgery [ Time Frame: 12 months postoperatively ]

opacification of visual axis


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • inflammation on slitlamp examination [ Time Frame: 12 months postoperatively ]
    cell depostis
  • inflammation on slitlamp examination [ Time Frame: 12 months postoperatively ]
    posterior synechiae
  • intraocular pressure in mmHg [ Time Frame: 12 months postoperatively ]
    glaucoma


Original Secondary Outcome: Same as current

Information By: Iladevi Cataract and IOL Research Center

Dates:
Date Received: June 29, 2015
Date Started: April 2013
Date Completion:
Last Updated: July 2, 2015
Last Verified: July 2015