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Clinical Trials/NCT06070883
NCT06070883
Completed
Not Applicable

Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis

Al-Azhar University1 site in 1 country26 target enrollmentJanuary 1, 2022
ConditionsKeratitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Keratitis
Sponsor
Al-Azhar University
Enrollment
26
Locations
1
Primary Endpoint
Corneal Pain
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Corneal infection or infectious keratitis (IK) is the most common cause of corneal blindness worldwide, particu-larly in the developing countries1. The incidence was estimated at 2.5-799 per 100,000 population/year. It is a painful and potentially blinding ocular emergency that often requires hospital admission for intensive medical and/or surgical treatment. Depending on the geographical and temporal variations and population-based risk factors (e.g. agricultural practice, trauma, use of contact lens and others), bacteria and fungi have been shown to be the main causative microorganisms for IK, followed by viruses, parasites and polymicrobial infection. Amniotic membrane (AM) is the innermost layer of the placenta, which consists of a single layer of meta-bolically active epithelium, a thick basement membrane, and an avascular stromal matrix (15).

It has been shown to exhibit a wide array of biological properties, including wound healing, anti-inflammatory, antimicrobial, and anti-angiogenic properties, amongst others. To date, a number of studies have evaluated the benefit of AMT for treating active IK, though the majority of them were of small case series or case reports. In clinical practice, AMT is usually reserved as a second-line therapy in IK, mainly to promote cornea healing in non-healing ulcer after the sterilization phase.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
October 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ehab Tharwat

Principal investigator

Al-Azhar University

Eligibility Criteria

Inclusion Criteria

  • Size more than 5 mm.
  • Deep ulcers i.e. \> 50% stromal thickness.
  • Located within 3mm of the visual axis.
  • Patients with descemetoceles and corneal perforations will also be included

Exclusion Criteria

  • Corneal ulcers of size \< 5mm depth \< 50%
  • Associated glaucoma
  • Associated chronic dacryocystitis
  • Ulcers with entropion

Outcomes

Primary Outcomes

Corneal Pain

Time Frame: three months post operative

it will be meaured by the Visual analouge scale

Size of the ulcer

Time Frame: three months post operative

it will be meaured in mellimeter

Study Sites (1)

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