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OpenTrials
Completed

NCT Number: NCT01504607

Corneal Endothelial Changes Following Pediatric Cataract Surgery With IOL Implantation

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.

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Key information

Conditions

Congenital Cataract Surgery Change in Corneal Endothelial Cell Morphology IOL Implantation

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Congenital Cataract Surgery

Procedure

Congenital cataract surgery with IOL implantation

Primary outcomes

  1. 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

  1. Change in central corneal thickness

    Time frame: preoperatively to 3 months postoperatively

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

Sponsors and collaborators

Lead sponsor

Iladevi Cataract and IOL Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 5, 2012
Registry last updated
Jan 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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