Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis

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.

Study Overview

• Status: Completed
• Conditions: Keratitis
• Intervention / Treatment: Procedure: Amniotic membrane transplantation

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • New Damietta
    • Damieta, New Damietta, Egypt, 34517
      • Ehab tharwat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Amniotic membrane; 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.It has been shown to exhibit a wide array of biological properties, including wound healing, anti-inflammatory, antimicrobial, and anti-angiogenic properties, amongst others

Procedure: Amniotic membrane transplantation; 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. It has been shown to exhibit a wide array of biological properties, including wound healing, anti-inflammatory, antimicrobial, and anti-angiogenic properties, amongst others. Amniotic membrane transplantation will be performed in eye OT under aseptic conditions. The necrotic tissues at the base of the ulcer will be debrided and sent for culture and sensitivity. The rolledup edge of the ulcer or the loosely adhered epithelium adjacent to the ulcer will also be removed. The amniotic membrane will be trimmed to fit the shape of the ulcer and placed with its epithelial side up. Then the amniotic membrane will be secured with 10-0 nylon suture (5 cases with interrupted and 25 cases with continuous suture) with the suture knots buried.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Pain	it will be meaured by the Visual analouge scale	Baseline
Corneal Pain	it will be meaured by the Visual analouge scale	one month post operative
Corneal Pain	it will be meaured by the Visual analouge scale	three months post operative
Size of the ulcer	it will be meaured in mellimeter	Baseline
Size of the ulcer	it will be meaured in mellimeter	one month post operative
Size of the ulcer	it will be meaured in mellimeter	three months post operative

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): September 8, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: October 1, 2023
• First Submitted That Met QC Criteria: October 1, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratitis
• Other Study ID Numbers: Resistant fungal keratitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No