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

History of Changes

Tracking Information
First Received Date ^ICMJE	December 27, 2011
Last Updated Date	January 3, 2012
Start Date ^ICMJE	January 2011
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 3, 2012)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01504607 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 3, 2012)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Corneal Endothelial Changes Following Pediatric Cataract Surgery With IOL Implantation
Official Title ^ICMJE	Corneal Endothelial Morphologic Assessment in Pediatric Cataract Surgery With IOL Implantation: Comparison of Preoperative and Early Postoperative Specular Microscopy
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 Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Children older than 4 years undergoing cataract surgery with IOL implantation were included.
Condition ^ICMJE	Congenital Cataract Surgery IOL Implantation Change in Corneal Endothelial Cell Morphology
Intervention ^ICMJE	Procedure: Congenital Cataract Surgery Congenital cataract surgery with IOL implantation
Study Group/Cohort (s)	Congenital cataract surgery with IOL implantation Congenital cataract surgery was performed with or without anterior vitrectomy, followed by in the bag IOL implantation Intervention: Procedure: Congenital Cataract Surgery
Publications *	Vasavada AR, Praveen MR, Vasavada VA, Shah SK, Vasavada V, Trivedi RH. Corneal endothelial morphologic assessment in pediatric cataract surgery with intraocular lens implantation: a comparison of preoperative and early postoperative specular microscopy. Am J Ophthalmol. 2012 Aug;154(2):259-265.e1. Epub 2012 Apr 27.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	106
Completion Date	October 2011
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	4 Years to 15 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01504607
Other Study ID Numbers ^ICMJE	ICIRC-Pedspec, 2011-13
Has Data Monitoring Committee	Yes
Responsible Party	Iladevi Cataract and IOL Research Center
Study Sponsor ^ICMJE	Iladevi Cataract and IOL Research Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Iladevi Cataract and IOL Research Center
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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