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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Posterior Capsule Opacification
- Sponsor
- Iladevi Cataract and IOL Research Center
- Enrollment
- 61
- Primary Endpoint
- Posterior capsule opacification requiring surgery
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Abhay R. Vasavada
Director
Iladevi Cataract and IOL Research Center
Eligibility Criteria
Inclusion Criteria
- •uncomplicated cataract,
- •unilateral or bilateral cataract,
- •corneal diameter \>9.0mmHg
Exclusion Criteria
- •pre-existing glaucoma,
- •ocular comorbidity,
- •microphthalmos,
- •microcornea,
- •parents not consenting to participate in study,
- •traumatic cataract
Outcomes
Primary Outcomes
Posterior capsule opacification requiring surgery
Time Frame: 12 months postoperatively
opacification of visual axis
Secondary Outcomes
- intraocular pressure in mmHg(12 months postoperatively)
- inflammation on slitlamp examination(12 months postoperatively)