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Corneal Endothelial Changes Following Pediatric Cataract Surgery With IOL Implantation

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ClinicalTrials.gov Identifier: NCT01504607
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : January 5, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Cataract surgery is known to cause loss of corneal endothelial cells. In adults, it is reported that anywhere between 2 to 15% loss of corneal endothelial cell density occurs following cataract surgery. However, no data is available regarding endothelial changes after cataract surgery with IOL implantation in pediatric eyes.

The aim of this study is to prospectively observe changes in endothelial cell density, coefficient of variation and hexagonality following cataract surgery with IOL implantation in pediatric eyes.


Condition or disease Intervention/treatment
Congenital Cataract Surgery IOL Implantation Change in Corneal Endothelial Cell Morphology Procedure: Congenital Cataract Surgery

Study Design

Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Corneal Endothelial Morphologic Assessment in Pediatric Cataract Surgery With IOL Implantation: Comparison of Preoperative and Early Postoperative Specular Microscopy
Study Start Date : January 2011
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Congenital cataract surgery with IOL implantation
Congenital cataract surgery was performed with or without anterior vitrectomy, followed by in the bag IOL implantation
Procedure: Congenital Cataract Surgery
Congenital cataract surgery with IOL implantation


Outcome Measures

Primary Outcome Measures :
  1. Corneal endothelial morphology [ Time Frame: preoperatively to 3 months postoperatively ]
    Change in corneal endothelial cell density, (CD), coefficient of variation (CV) and % of hexagonality (6A) were studied from preoperatively to 3 months postoperatively


Secondary Outcome Measures :
  1. Change in central corneal thickness [ Time Frame: preoperatively to 3 months postoperatively ]
    Change in central corneal thickness from preop to 3 months postop was studied


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children older than 4 years undergoing cataract surgery with IOL implantation were included.
Criteria

Inclusion Criteria:

  • Eyes undergoing pediatric cataract surgery with IOL implantation at Iladevi Cataract & IOL Research Center, Ahmedabad, India.
  • Children older than 4 years undergoing cataract surgery with IOL implantation were included.

Exclusion Criteria:

  • Exclusion criteria were as follows: eyes with traumatic or subluxated cataract and inability to get preoperative specular. Intraoperatively, sulcus fixated IOLs, and eyes with no IOL implantation were excluded.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier: NCT01504607     History of Changes
Other Study ID Numbers: ICIRC-Pedspec
2011-13 ( Other Identifier: ICIRC )
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012

Keywords provided by Iladevi Cataract and IOL Research Center:
corneal endothelium
congenital cataract surgery
IOL implantation

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases