Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- variation in cell size
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with cataract scheduled for surgery
Exclusion Criteria
- •Patients with corneal diseases, glaucoma or uveitis, previous intraocular surgery or eye traumas.
Outcomes
Primary Outcomes
variation in cell size
corneal endothelial cell count (cells / mm2)
percentage of hexagonal cells
central corneal thickness
Secondary Outcomes
- intraocular pressure
- visual acuity