CORNEAL EPITHELIAL MAPPING IN DIABETICS

April 9, 2024 updated by: Hosny Ahmed Zein, Minia University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61111
        • Minia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

It's a prospective cross section study. 159 eyes of 159 patients will be involved in this study, divided into three groups: (Group A) 53 eyes of diabetic patients with diabetic macular edema, (Group B) 53 eyes of diabetic patients without macular edema and (group C) 53 eyes of age matched control.

Description

Inclusion Criteria:

  1. The patients aged between 40- 60 years old of both genders.
  2. 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).
  3. 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).
  4. The patients in (Group C) should be free of any systemic diseases and normal macular thickness (by OCT)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy control
Other: corneal imaging
corneal imaging using AS-OCT
Diabetics with macular edema
Other: corneal imaging
corneal imaging using AS-OCT
Diabetics without macular edema
Other: corneal imaging
corneal imaging using AS-OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corneal epithelial thickness
Time Frame: 2 years
corneal thickness in diabetics using OCT
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

January 28, 2021

First Posted (Actual)

February 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MiniaUN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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