Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis

Al-Azhar University

Status: Completed

Conditions: Keratitis

Treatments: Procedure: Amniotic membrane transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06070883

Resistant fungal keratitis

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Amniotic membrane

Other group

Description:

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

Treatment:

Procedure: Amniotic membrane transplantation