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

Iladevi Cataract and IOL Research Center

Status: Completed

Conditions: Postoperative Complications; Posterior Capsule Opacification

Treatments: Procedure: cataract surgery; Procedure: Intraocular lens implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02491918

13-009

2013 Research Foundation Grant (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 15 days to 4 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

In the bag IOL

Active Comparator group

Description:

Cataract surgery with IOL implantation in the capsular bag

Treatment:

Procedure: Intraocular lens implantation

Procedure: cataract surgery

Optic Capture of IOL

Active Comparator group

Description:

intraocular lens implantation in the capsular bag with posterior optic capture

Treatment:

Procedure: Intraocular lens implantation

Procedure: cataract surgery