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Clinical Trials/NCT05522842
NCT05522842Not yet recruitingNot Applicable

Evaluation of Corneal Endothelium in Diabetic Patients Undergoing Phacoemulsification Using Specular Microscopy

Assiut University0 sites50 target enrollmentStarted: November 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rahma Rashad Helmy

doctor

Assiut University

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