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NCT Number: NCT02491918

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

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.

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Key information

Conditions

Posterior Capsule Opacification Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

15 day–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cataract surgery

Procedure

cataract surgery in children

Intraocular lens implantation

Procedure

intraocular lens implantation in the capsular bag or optic capture

Primary outcomes

  1. Posterior capsule opacification requiring surgery

    Time frame: 12 months postoperatively

    opacification of visual axis

Secondary outcomes

  1. inflammation on slitlamp examination

    Time frame: 12 months postoperatively

    cell depostis

  2. inflammation on slitlamp examination

    Time frame: 12 months postoperatively

    posterior synechiae

  3. intraocular pressure in mmHg

    Time frame: 12 months postoperatively

    glaucoma

Sponsors and collaborators

Lead sponsor

Iladevi Cataract and IOL Research Center

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 8, 2015
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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