Corneal Endothelial Changes Following Pediatric Cataract Surgery With IOL Implantation

Change in Corneal Endothelial Cell Morphology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504607
• Other study ID #: ICIRC-Pedspec
• Secondary ID: 2011-13
• Status: Completed
• Phase: N/A
• First received: December 27, 2011
• Last updated: January 3, 2012
• Start date: January 2011
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: Iladevi Cataract and IOL Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: India : Iladevi Cataract & IOL Research Centre, Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 15 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cataract
• Change in Corneal Endothelial Cell Morphology
• Congenital Cataract Surgery
• IOL Implantation

Intervention

Procedure:
• Congenital Cataract Surgery
Congenital cataract surgery with IOL implantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iladevi Cataract and IOL Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal endothelial morphology	Change in corneal endothelial cell density, (CD), coefficient of variation (CV) and % of hexagonality (6A) were studied from preoperatively to 3 months postoperatively	preoperatively to 3 months postoperatively	No
Secondary	Change in central corneal thickness	Change in central corneal thickness from preop to 3 months postop was studied	preoperatively to 3 months postoperatively	No