CORNEAL EPITHELIAL MAPPING IN DIABETICS

Cornea Epithelial Mapping Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04734158
• Other study ID #: MiniaUN
• Status: Active, not recruiting
• Start date: August 12, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 153
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cornea Epithelial Mapping
• Corneal Diseases

Intervention

Other:
• corneal imaging
corneal imaging using AS-OCT

Locations

Country	Name	City	State
Egypt	Minia University	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	corneal epithelial thickness	corneal thickness in diabetics using OCT	2 years