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Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis

Primary Purpose

Keratitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Amniotic membrane transplantation
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratitis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ehab tharwat

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Amniotic membrane

Arm 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

Outcomes

Primary Outcome Measures

Corneal Pain
it will be meaured by the Visual analouge scale
Corneal Pain
it will be meaured by the Visual analouge scale
Corneal Pain
it will be meaured by the Visual analouge scale
Size of the ulcer
it will be meaured in mellimeter
Size of the ulcer
it will be meaured in mellimeter
Size of the ulcer
it will be meaured in mellimeter

Secondary Outcome Measures

Full Information

First Posted
October 1, 2023
Last Updated
October 1, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT06070883
Brief Title
Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis
Official Title
Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
September 8, 2023 (Actual)
Study Completion Date
October 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amniotic membrane
Arm Type
Other
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Amniotic membrane transplantation
Intervention 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. 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.
Primary Outcome Measure Information:
Title
Corneal Pain
Description
it will be meaured by the Visual analouge scale
Time Frame
Baseline
Title
Corneal Pain
Description
it will be meaured by the Visual analouge scale
Time Frame
one month post operative
Title
Corneal Pain
Description
it will be meaured by the Visual analouge scale
Time Frame
three months post operative
Title
Size of the ulcer
Description
it will be meaured in mellimeter
Time Frame
Baseline
Title
Size of the ulcer
Description
it will be meaured in mellimeter
Time Frame
one month post operative
Title
Size of the ulcer
Description
it will be meaured in mellimeter
Time Frame
three months post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ehab tharwat
City
Damieta
State/Province
New Damietta
ZIP/Postal Code
34517
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis

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