Corneal Endothelial Changes Following Pediatric Cataract Surgery With IOL Implantation

• Sponsor: Iladevi Cataract and IOL Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01504607
• Collaborator: (none)
• Enrollment: 106
• Duration (Months): 9

Study Details

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	Phase
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: Jan 1, 2011
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	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 [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 [preoperatively to 3 months postoperatively]

   Change in central corneal thickness from preop to 3 months postop was studied

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Iladevi Cataract and IOL Research Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Iladevi Cataract and IOL Research Center
• ClinicalTrials.gov Identifier: NCT01504607
• Other Study ID Numbers: ICIRC-Pedspec; 2011-13
• First Posted: Jan 5, 2012
• Last Update Posted: Jan 5, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by Iladevi Cataract and IOL Research Center: corneal endothelium; congenital cataract surgery; IOL implantation
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Jan 5, 2012