Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis

NCT ID: NCT06070883

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-10-01

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.

Conditions

Keratitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Amniotic membrane transplantation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Ehab Tharwat

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ehab tharwat

Damietta, New Damietta, Egypt

Countries

Egypt

Other Identifiers

Resistant fungal keratitis

Identifier Type: -

Identifier Source: org_study_id