CORNEAL EPITHELIAL MAPPING IN DIABETICS

Active, not recruiting

• Conditions: Cornea Epithelial Mapping
• Interventions: Other: corneal imaging

• Registration Number: NCT04734158
• Lead Sponsor: Minia University

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.

Study Timeline

• Study Start: 2019-08-12
• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-02-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 153

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy control	corneal imaging	-
Diabetics with macular edema	corneal imaging	-
Diabetics without macular edema	corneal imaging	-

Primary Outcome Measures

Name	Time	Method
corneal epithelial thickness	2 years	corneal thickness in diabetics using OCT

Trial Locations

Locations (1)

Minia University; 🇪🇬 Minya, Egypt