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

Study Overview
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Brief Summary
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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
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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 : in the bag IOL with limbal anterior vitrectomy 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.

Official Title
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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

Conditions
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Posterior Capsule Opacification, Postoperative Complications

Intervention / Treatment
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* Procedure: cataract surgery
* Procedure: Intraocular lens implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Days
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |