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Completed

NCT Number: NCT06070883

Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis

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.

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Key information

Conditions

Keratitis Corneal Diseases Eye Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ehab tharwat

Damietta, New Damietta, 34517, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Corneal Pain

    Time frame: Baseline

    it will be meaured by the Visual analouge scale

  2. Corneal Pain

    Time frame: one month post operative

    it will be meaured by the Visual analouge scale

  3. Corneal Pain

    Time frame: three months post operative

    it will be meaured by the Visual analouge scale

  4. Size of the ulcer

    Time frame: Baseline

    it will be meaured in mellimeter

  5. Size of the ulcer

    Time frame: one month post operative

    it will be meaured in mellimeter

  6. Size of the ulcer

    Time frame: three months post operative

    it will be meaured in mellimeter

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 6, 2023
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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