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

Sponsor
Iladevi Cataract and IOL Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT02491918
Collaborator
(none)
61
Enrollment
2
Arms
24
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: cataract surgery
  • Procedure: Intraocular lens implantation
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
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
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: In the bag IOL

Cataract surgery with IOL implantation in the capsular bag

Procedure: cataract surgery
cataract surgery in children

Procedure: Intraocular lens implantation
intraocular lens implantation in the capsular bag or optic capture
Active Comparator: Optic Capture of IOL

intraocular lens implantation in the capsular bag with posterior optic capture

Procedure: cataract surgery
cataract surgery in children

Procedure: Intraocular lens implantation
intraocular lens implantation in the capsular bag or optic capture

Outcome Measures

Primary Outcome Measures

  1. Posterior capsule opacification requiring surgery [12 months postoperatively]

    opacification of visual axis

Secondary Outcome Measures

  1. inflammation on slitlamp examination [12 months postoperatively]

    cell depostis

  2. inflammation on slitlamp examination [12 months postoperatively]

    posterior synechiae

  3. intraocular pressure in mmHg [12 months postoperatively]

    glaucoma

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Days to 4 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Iladevi Cataract and IOL Research Center

Investigators

  • Study Director: abhay vasavada, MS,FRCS, Iladevi Cataract & IOL Research Centre, Ahmedabad, India

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abhay R. Vasavada, Director, Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT02491918
Other Study ID Numbers:
  • 13-009
  • 2013 Research Foundation Grant
First Posted:
Jul 8, 2015
Last Update Posted:
Jul 8, 2015
Last Verified:
Jul 1, 2015
Additional relevant MeSH terms:
Cataract
Capsule Opacification
Postoperative Complications

Study Results

No Results Posted as of Jul 8, 2015