Clinical Trial: Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery

Study Status: Suspended
Recruit Status: Suspended
Study Type: Observational

Official Title: Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery

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 Summary:

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.


Sponsor: Frederiksberg University Hospital

Current Primary Outcome:

  • corneal endothelial cell count (cells / mm2)
  • percentage of hexagonal cells
  • variation in cell size
  • central corneal thickness


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • visual acuity
  • intraocular pressure


Original Secondary Outcome: Same as current

Information By: Frederiksberg University Hospital

Dates:
Date Received: March 9, 2007
Date Started: January 2007
Date Completion: June 2007
Last Updated: May 9, 2008
Last Verified: May 2008