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

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ClinicalTrials.gov Identifier: NCT02491918
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Abhay R. Vasavada, Iladevi Cataract and IOL Research Center

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
Posterior Capsule Opacification Postoperative Complications Procedure: cataract surgery Procedure: Intraocular lens implantation Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : April 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Posterior capsule opacification requiring surgery [ Time Frame: 12 months postoperatively ]
    opacification of visual axis


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491918


Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
Investigators
Study Director: abhay vasavada, MS,FRCS Iladevi Cataract & IOL Research Centre, Ahmedabad, India

Responsible Party: Abhay R. Vasavada, Director, Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier: NCT02491918     History of Changes
Other Study ID Numbers: 13-009
2013 Research Foundation Grant ( Other Grant/Funding Number: ASCRS Foundation Research Grant )
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Cataract
Postoperative Complications
Capsule Opacification
Lens Diseases
Eye Diseases
Pathologic Processes