Efficiency of the cryopreserved allogeneic amniotic membrane transplantation in patients with infectious and neurotrophic keratitis
Most clinical trials demonstrate a rapid decrease in the inflammatory reaction and a fast reepithelialization due to allogeneic amniotic membrane (AM) transplantation in case of severe ulcerative keratitis that may help to avoid an emergency keratoplasty and improves the prognosis of the elective keratoplasty. Therefore, AM transplantation could be a very promising approach to in attenuate inflammation of cornea, to trigger reepitelisation and to preserve health cornea structure without blood vessel growing in patients with infectious and neurotrophic keratitis
Study aim: to evaluate of efficiency and safety of cryopreserved allogeneic amniotic membrane (AM) transplantation in the patients with different corneal pathologies
- Еfficiency and safety of cryopreserved allogeneic AM transplantation: assessing by fixing clinical results and reviewing adverse events at 1, 3, 6, 12, 18 and 24 months post-procedure
- Major adverse events were adjudicated: hospitalization, tumor formation, vision loss
Dosing regimen:Experimental: Keratitis + AM:
Experimental Group 1: Allogeneic AM transplantation
Inlay (graft transplantation) – AM is placed directly on the area of the injured cornea, without covering of the intact area. AM was fixed to the defect by separate sutures 10/0. 2-4 amniotic membrane layers were fixed with interrupted 10/0 sutures to the edge of the corneal defect. As a result, the AM plays the role of a basement membrane, and stimulate the epithelial cells to migrate and crawl forward to the cornea defect
Experimental Group 2: Biological covering with Allogeneic AM
Only (biological covering) – the entire corneal surface, including limbal area, was covered with amniotic membrane and fixed by episcleral interrupted sutures 8/0
By this technique, the amniotic membrane plays primarily the role of a biological contact lens
Experimental Group 3: Combined (sandwich) technique
Sandwich technique is a combination of the previous two, when the amniotic graft was fixed to the corneal defect and covered with amniotic layer using episcleral fixation
No HLA matching or immunosuppression required
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