Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis

Keratitis Clinical Trial

Official title:

Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06070883
• Other study ID #: Resistant fungal keratitis
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 1, 2023
• Est. primary completion date: September 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratitis

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ehab tharwat	Damieta	New Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Pain	it will be meaured by the Visual analouge scale	Baseline
Primary	Corneal Pain	it will be meaured by the Visual analouge scale	one month post operative
Primary	Corneal Pain	it will be meaured by the Visual analouge scale	three months post operative
Primary	Size of the ulcer	it will be meaured in mellimeter	Baseline
Primary	Size of the ulcer	it will be meaured in mellimeter	one month post operative
Primary	Size of the ulcer	it will be meaured in mellimeter	three months post operative