Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes Mellitus Type II

Diabetes Clinical Trial

Official title:

Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078103
• Other study ID #: J.nr.2005-41-4933
• Status: Completed
• Phase: Phase 4
• First received: March 1, 2010
• Last updated: March 1, 2010
• Start date: July 2005
• Est. completion date: April 2008

Study information

• Verified date: August 2009
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Cataract, diabetes

Exclusion Criteria:

• Corneal disease

• Uveitis

• Previous intraocular surgery and diabetes type I

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cataract
• Diabetes

Locations

Country	Name	City	State
Denmark	Frederiksberg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark,