Postoperative Complications Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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