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Clinical Trials/NCT04734158
NCT04734158
Active, not recruiting
Not Applicable

EVALUATION OF CORNEAL EPITHELIAL THICKNESS MAPPING IN DIABETIC PATIENTS USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND ITS CORRELATION TO MACULAR THICKNESS

Minia University1 site in 1 country153 target enrollmentAugust 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cornea Epithelial Mapping
Sponsor
Minia University
Enrollment
153
Locations
1
Primary Endpoint
corneal epithelial thickness
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

The corneal epithelium is the outermost layer that covers the front of the eye; it not only functions as a barrier that blocks the passage of foreign material, but also plays an important role in maintaining high optical quality. The stem cells in the basal layer of the limbal epithelium hold a physiological significance in the renewal and metabolism of corneal epithelium, particularly under stressful situations.

Detailed Description

The cornea in diabetic patients suffers from cellular dysfunction and dysfunctional repairal mechanisms, which include recurrent erosions, delayed wound healing, ulcers, and edema. In addition and undoubtedly related to epithelial dysfunction, alterations in epithelial basement membrane occur.

Registry
clinicaltrials.gov
Start Date
August 12, 2019
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Minia University
Responsible Party
Principal Investigator
Principal Investigator

Hosny Ahmed Zein

DR. HOSNY AHMED ZEIN

Minia University

Eligibility Criteria

Inclusion Criteria

  • The patients aged between 40- 60 years old of both genders.
  • The patients in (Group A) should be diabetics for more than 10 years and free from any other systemic diseases with diabetic macular edema (by OCT).
  • The patients in (Group B) should be diabetics for more than 10 years and free from any other systemic diseases without diabetic macular edema (by OCT).
  • The patients in (Group C) should be free of any systemic diseases and normal macular thickness (by OCT)

Exclusion Criteria

  • Previous history of any intraocular surgery, intravitreal injection, laser or refractive surgery.
  • Ocular surface disorders (e.g. dry eye) or any corneal pathology.
  • Corneal scars or epithelial dystrophies.
  • Use of any topical medications.
  • Elevated IOP, pregnancy or lactation.

Outcomes

Primary Outcomes

corneal epithelial thickness

Time Frame: 2 years

corneal thickness in diabetics using OCT

Study Sites (1)

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