An interventional study of Amniotic membrane transplantation in Keratitis, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
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.
129 studies on the registry are indexed under Keratitis; 14 are open to participants now.
This study's enrollment of 26 is below the median of 36 across 80 interventional studies indexed under Keratitis.
Browse Keratitis studies →Al-Azhar University is the lead sponsor of 525 studies on the registry; 171 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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
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.
Corneal Pain
it will be meaured by the Visual analouge scale
Time frame: Baseline
Corneal Pain
it will be meaured by the Visual analouge scale
Time frame: one month post operative
Corneal Pain
it will be meaured by the Visual analouge scale
Time frame: three months post operative
Size of the ulcer
it will be meaured in mellimeter
Time frame: Baseline
Size of the ulcer
it will be meaured in mellimeter
Time frame: one month post operative
Size of the ulcer
it will be meaured in mellimeter
Time frame: three months post operative
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in Sep 2023, 20 months.
Of 17 interventional studies with no phase under Keratitis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's 20 months is close to that.
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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