Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis

NCT06070883 | Completed

• 1 other identifier: Resistant fungal keratitis
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Amniotic membrane

OTHER

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

Interventions

Amniotic membrane transplantation 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.

Amniotic membrane

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Corneal ulcers of size \< 5mm depth \< 50%
• Associated glaucoma
• Associated chronic dacryocystitis
• Ulcers with entropion

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Ehab tharwat

Damietta, New Damietta, 34517, Egypt

Location

MeSH Terms

Conditions

Keratitis

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 6, 2023
• Study Start: January 1, 2022
• Primary Completion: September 8, 2023
• Study Completion: October 1, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)