Evaluation of Corneal Endothelium in Diabetic Patients Undergoing Phacoemulsification Using Specular Microscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 50
- Primary Endpoint
- corneal endothelial cell size
Study Overview
Brief Summary
evaluate and compare the changes in corneal endothelial cell count density between diabetic and non diabetic patients undergoing phacoemulsification surgery, and to evaluate the effect of duration, and control of diabetes on corneal morphology.
Detailed Description
Diabetes mellitus (DM) is a major health hazard reaching epidemic proportions. Worldwide more than 285 million people are affected by DM; this number is expected to increase to 439 million by 2030 according to the international diabetes federation. DM affects every part of the body and the eye is not an exception.
Diabetes mellitus has been found to be detrimental to corneal endothelium . Patients with diabetes have been found to have morphologically abnormal endothelium, including pleomorphism and polymegethism. Also, elderly patients with diabetes mellitus undergo phacoemulsification is particularly vulnerable to greater endothelial damage during surgery than non diabetics.
Several studies showed that diabetes mellitus has a lower impact on corneal cell density and morphology in patients with good glycemic control , also patients with diabetes over 10 years have more corneal morphological abnormalities than those having diabetes under 10 years duration.
Patients with DM tend to develop cataract more frequently and earlier than non diabetics.
Corneal endothelium plays an important role in maintaining dehydrated state and transparency of cornea throughout life, by pumping excess fluid out of stroma through active transport mechanism and barrier function. Any compromise in these factors leads to direct effect on corneal endothelium .
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age from 40 to 70
- •Any degree of cataract
- •No previous ocular surgery
Exclusion Criteria
- •Any corneal pathology, infection, or active inflammation
- •pseudoexofoliation
- •History of ocular trauma or surgery
Outcomes
Primary Outcomes
corneal endothelial cell size
Time Frame: baseline
their dimension being roughly 50-70 μm long, 10-30 μm wide and 0.1-10 μm thick
corneal endothelium cell count
Time Frame: baseline
normal range of 1500 to 3500 cells/mm2 (age, 40-90)
corneal endothelial cell shape
Time Frame: baseline
a single layer of cells organized in a characteristic honeycomb pattern
Secondary Outcomes
No secondary outcomes reported
Investigators
Rahma Rashad Helmy
doctor
Assiut University
