CORNEAL EPITHELIAL MAPPING IN DIABETICS

Sponsor
Minia University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04734158
Collaborator
(none)
153
1
52.6
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: corneal imaging

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 Design

Study Type:
Observational
Anticipated Enrollment :
153 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
EVALUATION OF CORNEAL EPITHELIAL THICKNESS MAPPING IN DIABETIC PATIENTS USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND ITS CORRELATION TO MACULAR THICKNESS
Actual Study Start Date :
Aug 12, 2019
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. corneal epithelial thickness [2 years]

    corneal thickness in diabetics using OCT

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Minia University Minya Egypt 61111

Sponsors and Collaborators

  • Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hosny Ahmed Zein, DR. HOSNY AHMED ZEIN, Minia University
ClinicalTrials.gov Identifier:
NCT04734158
Other Study ID Numbers:
  • MiniaUN
First Posted:
Feb 2, 2021
Last Update Posted:
Jul 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hosny Ahmed Zein, DR. HOSNY AHMED ZEIN, Minia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2022