Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes Mellitus Type II

Completed

• Conditions: Diabetes; Cataract

• Registration Number: NCT01078103
• Lead Sponsor: Frederiksberg University Hospital

Brief Summary

Some studies indicated that the diabetic corneal endothelium is morphologically abnormal and may be at risk in any intraocular surgical procedure, while others showed no significant differences between diabetic and non-diabetic corneal endothelium.The purpose of this study is to investigate the differences in corneal endothelial cell density and morphology in diabetic patients and normal patients after phacoemulsification with intraocular lens implantation.To investigate if haemoglobin A1c can be used as a predictor of corneal endothelial cell changes after phacoemulsification.

Detailed Description

Some studies indicated that the diabetic corneal endothelium is morphologically abnormal and may be at risk in any intraocular surgical procedure, while others showed no significant differences between diabetic and non-diabetic corneal endothelium.The purpose of this study is to investigate the differences in corneal endothelial cell density and morphology in diabetic patients and normal patients after phacoemulsification with intraocular lens implantation.To investigate if haemoglobin A1c can be used as a predictor of corneal endothelial cell changes after phacoemulsification.

Specular microscopy photos will be taken pre-. and 3 month postoperatively. Cellular parameters will be compared between the two groups prior and post surgery. Clinical significant difference is defined as 1 SD (300 cell/mm2)

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2009-08
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-01
• Last Update Submitted: 2010-03-01
• Study First Posted: 2010-03-02
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Cataract, diabetes

Exclusion Criteria

• Corneal disease
• Uveitis
• Previous intraocular surgery and diabetes type I

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Frederiksberg Hospital; 🇩🇰 Copenhagen, Denmark