Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis

Not Applicable

Completed

• Conditions: Keratitis
• Interventions: Procedure: Amniotic membrane transplantation

• Registration Number: NCT06070883
• Lead Sponsor: Al-Azhar University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-09-08
• Status Verified: 2023-10
• Study Completion: 2023-10-01
• Study First Submitted: 2023-10-01
• Study First Submitted QC: 2023-10-01
• Last Update Submitted: 2023-10-01
• Study First Posted: 2023-10-06
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amniotic membrane	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

Primary Outcome Measures

Name	Time	Method
Corneal Pain	three months post operative	it will be meaured by the Visual analouge scale
Size of the ulcer	three months post operative	it will be meaured in mellimeter

Trial Locations

Locations (1)

Ehab tharwat; 🇪🇬 Damieta, New Damietta, Egypt