Corneal Endothelial Changes Following Pediatric Cataract Surgery With IOL Implantation
Corneal Endothelial Morphologic Assessment in Pediatric Cataract Surgery With IOL Implantation: Comparison of Preoperative and Early Postoperative Specular Microscopy
2 other identifiers
observational
106
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2011
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 27, 2011
CompletedFirst Posted
Study publicly available on registry
January 5, 2012
CompletedJanuary 5, 2012
January 1, 2012
9 months
December 27, 2011
January 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Change in central corneal thickness
preoperatively to 3 months postoperatively
Study Arms (1)
Congenital cataract surgery with IOL implantation
Congenital cataract surgery was performed with or without anterior vitrectomy, followed by in the bag IOL implantation
Interventions
Congenital cataract surgery with IOL implantation
Eligibility Criteria
Children older than 4 years undergoing cataract surgery with IOL implantation were included.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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. doi: 10.1016/j.ajo.2012.02.018. Epub 2012 Apr 27.
PMID: 22541660DERIVED
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2011
First Posted
January 5, 2012
Study Start
January 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
January 5, 2012
Record last verified: 2012-01