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Clinical Trials/NCT01504607
NCT01504607
Completed
Not Applicable

Corneal Endothelial Morphologic Assessment in Pediatric Cataract Surgery With IOL Implantation: Comparison of Preoperative and Early Postoperative Specular Microscopy

Iladevi Cataract and IOL Research Center0 sites106 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Cataract Surgery
Sponsor
Iladevi Cataract and IOL Research Center
Enrollment
106
Primary Endpoint
Corneal endothelial morphology
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
October 2011
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Iladevi Cataract and IOL Research Center
Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

  • Change in central corneal thickness(preoperatively to 3 months postoperatively)

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