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CORNEAL EPITHELIAL MAPPING IN DIABETICS

M

Minia University

Status

Active, not recruiting

Conditions

Cornea Epithelial Mapping

Treatments

Other: corneal imaging

Study type

Observational

Funder types

Other

Identifiers

NCT04734158
MiniaUN

Details and patient eligibility

About

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.

Full 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.

Enrollment

153 estimated patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

153 participants in 3 patient groups

Healthy control
Treatment:
Other: corneal imaging
Diabetics with macular edema
Treatment:
Other: corneal imaging
Diabetics without macular edema
Treatment:
Other: corneal imaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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