Corneal Endothelial Changes Following Pediatric Cataract Surgery With IOL Implantation

Completed

• Conditions: Congenital Cataract Surgery; IOL Implantation; Change in Corneal Endothelial Cell Morphology
• Interventions: Procedure: Congenital Cataract Surgery

• Registration Number: NCT01504607
• Lead Sponsor: Iladevi Cataract and IOL Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2011-12-27
• Status Verified: 2012-01
• Study First Submitted QC: 2012-01-03
• Last Update Submitted: 2012-01-03
• Study First Posted: 2012-01-05
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Congenital cataract surgery with IOL implantation	Congenital Cataract Surgery	Congenital cataract surgery was performed with or without anterior vitrectomy, followed by in the bag IOL implantation

Primary Outcome Measures

Name	Time	Method
Corneal endothelial morphology	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

Name	Time	Method
Change in central corneal thickness	preoperatively to 3 months postoperatively	Change in central corneal thickness from preop to 3 months postop was studied