Corneal Endothelial Changes Following Pediatric Cataract Surgery With IOL Implantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT01504607
First received: December 27, 2011
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

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 Intervention
Congenital Cataract Surgery
IOL Implantation
Change in Corneal Endothelial Cell Morphology
Procedure: Congenital Cataract Surgery

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Iladevi Cataract and IOL Research Center:

Primary Outcome Measures:
  • Corneal endothelial morphology [ Time Frame: preoperatively to 3 months postoperatively ] [ Designated as safety issue: No ]
    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:
  • Change in central corneal thickness [ Time Frame: preoperatively to 3 months postoperatively ] [ Designated as safety issue: No ]
    Change in central corneal thickness from preop to 3 months postop was studied


Enrollment: 106
Study Start Date: January 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Years to 15 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Iladevi Cataract and IOL Research Center

Additional 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
Study First Received: December 27, 2011
Last Updated: January 3, 2012
Health Authority: India : Iladevi Cataract & IOL Research Centre, Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2014