Viewing Study NCT00446277



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Study NCT ID: NCT00446277
Status: SUSPENDED
Last Update Posted: 2008-05-12
First Post: 2007-03-09

Brief Title: Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery
Sponsor: Frederiksberg University Hospital
Organization: Frederiksberg University Hospital

Study Overview

Official Title: Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery
Status: SUSPENDED
Status Verified Date: 2008-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: The present study was joining 2005-41-4933 into one study
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The aim of the present study is to evaluate changes in the morphology and function of the corneal endothelium before and after cataract surgery in patients with diabetes type II Also to explain if determination of HgbA1c in diabetics is a predictor for the changes in morphology and function
Detailed Description: Thirty patients with Diabetes type II and thirty non-diabetes patients scheduled to cataract surgery phacoemulsification with intraocular lens implantation were invited to participate in the study Preoperatively all patients had a full eye examination and 3 endothelial cell photos were taken

Three months postoperatively the patients were called for a re-examination including 3 endothelial cell photos The function of the cornea is dependent of the number and morphology of the endothelial cells and even small traumas like cataract surgery may disrupt the cornea integrity leading to corneal haze and blur Diabetics may be more vulnerable to corneal stress

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None