title: Sutureless fixation of amniotic membrane for therapy of ocular surface disorders.
abstract: Amniotic membrane is applied to the diseased ocular surface to stimulate wound healing and tissue repair, because it releases supportive growth factors and cytokines. These effects fade within about a week after application, necessitating repeated application. Generally, amniotic membrane is fixed with sutures to the ocular surface, but surgical intervention at the inflamed or diseased site can be detrimental. Therefore, we have developed a system for the mounting of amniotic membrane between two rings for application to a diseased ocular surface without surgical intervention (sutureless amniotic membrane transplantation). With this system, AmnioClip, amniotic membrane can be applied like a large contact lens. First prototypes were tested in an experiment on oneself for wearing comfort. The final system was tested on 7 patients in a pilot study. A possible influence of the ring system on the biological effects of amniotic membrane was analyzed by histochemistry and by analyzing the expression of vascular endothelial growth factor-A (VEGF-A), hepatocyte growth factor (HGF), fibroblast growth factor 2 (FGF 2) and pigment epithelium-derived factor (PEDF) from amniotic membranes before and after therapeutic application. The final product, AmnioClip, showed good tolerance and did not impair the biological effects of amniotic membrane. VEGF-A and PEDF mRNA was expressed in amniotic membrane after storage and mounting before transplantation, but was undetectable after a 7-day application period. Consequently, transplantation of amniotic membranes with AmnioClip provides a sutureless and hence improved therapeutic strategy for corneal surface disorders.Trial Registration:ClinicalTrials.gov NCT02168790
authors.affiliation: Department of Ophthalmology, Klinikum Chemnitz gGmbH, Chemnitz, Germany.
authors.forename: Ilya
authors.initials: I
authors.lastname: Kotomin
authors.affiliation: Institute of Anatomy, Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany.
authors.forename: Monika
authors.initials: M
authors.lastname: Valtink
authors.affiliation: Deutsche Gesellschaft für Gewebetransplantation, DGFG, Hannover, Germany.
authors.forename: Kai
authors.initials: K
authors.lastname: Hofmann
authors.affiliation: Division of Vascular Endothelium and Microcirculation, Department of Medicine III, TU Dresden, Dresden, Germany.
authors.forename: Annika
authors.initials: A
authors.lastname: Frenzel
authors.affiliation: Division of Vascular Endothelium and Microcirculation, Department of Medicine III, TU Dresden, Dresden, Germany; CRTD / DFG-Center for Regenerative Therapies Dresden-Cluster of Excellence, Dresden, Germany.
authors.forename: Henning
authors.initials: H
authors.lastname: Morawietz
authors.affiliation: CRTD / DFG-Center for Regenerative Therapies Dresden-Cluster of Excellence, Dresden, Germany; Leibniz-Institut für Polymerforschung Dresden e.V., Dresden, Germany.
authors.forename: Carsten
authors.initials: C
authors.lastname: Werner
authors.affiliation: Institute of Anatomy, Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany; CRTD / DFG-Center for Regenerative Therapies Dresden-Cluster of Excellence, Dresden, Germany.
authors.forename: Richard H W
authors.initials: RH
authors.lastname: Funk
authors.affiliation: Department of Ophthalmology, Klinikum Chemnitz gGmbH, Chemnitz, Germany; Deutsche Gesellschaft für Gewebetransplantation, DGFG, Hannover, Germany; CRTD / DFG-Center for Regenerative Therapies Dresden-Cluster of Excellence, Dresden, Germany.
authors.forename: Katrin
authors.initials: K
authors.lastname: Engelmann
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000650:Amnion / Q000378:metabolism / Q000601:surgery; D001684:Biological Dressings; D015415:Biomarkers / Q000378:metabolism; D003315:Cornea / Q000473:pathology*; D003316:Corneal Diseases / Q000473:pathology / Q000628:therapy*; D019573:Epithelium, Corneal / Q000473:pathology*; D004867:Equipment Design; D005136:Eye Proteins / Q000235:genetics / Q000378:metabolism; D005260:Female; D016222:Fibroblast Growth Factor 2 / Q000235:genetics / Q000378:metabolism; D015870:Gene Expression; D017228:Hepatocyte Growth Factor / Q000235:genetics / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D009414:Nerve Growth Factors / Q000235:genetics / Q000378:metabolism; D013508:Ophthalmologic Surgical Procedures / Q000295:instrumentation / Q000379:methods*; D010865:Pilot Projects; D015843:Serpins / Q000235:genetics / Q000378:metabolism; D042461:Vascular Endothelial Growth Factor A / Q000235:genetics / Q000378:metabolism; D000099174:Pigment Epithelium-Derived Factor
chemical_list: D015415:Biomarkers; D005136:Eye Proteins; D016222:Fibroblast Growth Factor 2; D017228:Hepatocyte Growth Factor; D009414:Nerve Growth Factors; D015843:Serpins; D042461:Vascular Endothelial Growth Factor A; D000099174:Pigment Epithelium-Derived Factor; C066855:HGF protein, human; C467484:VEGFA protein, human