Trials / Completed
CompletedNCT01078103
Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes Mellitus Type II
Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (actual)
- Sponsor
- Frederiksberg University Hospital · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2008-04-01
- Completion
- 2008-04-01
- First posted
- 2010-03-02
- Last updated
- 2010-03-02
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT01078103. Inclusion in this directory is not an endorsement.