title: [In vitro and in vivo investigations of a modified textile keratoprosthesis. ACTO TexKPRO].
abstract: BACKGROUND
  Clinical application of a keratoprosthesis (KPRO) is still a challenging task. Recent developments reflect the concepts of nut and bolt, intrastromal implantation or an osteoodontokeratoprosthesis (OOKP). A new concept of a textile KPRO has been evaluated in a limited human study with considerable difficulties which after termination of the study and considerable improvements was restarted using animal experiments.
  
  
  METHODS
  The ACTO TexKPRO is made from polyvinylidene difluoride (PVDF) fibers and transparent silicone. The first and second developmental stages differed in density and size of fibers and furthermore in surface modifications of the fibers and optics which were improved for the second prototype.
  
  
  METHODS
  Implantation of the prosthesis was performed in four patients with corneal blindness and in two cases retinal disease which required surgery. In the later animal experiments surgery was performed on three rabbits. Surgery was performed by redressing the conjunctiva, opening of the eyeball with a central 6.5 mm trephination, removal of the lens and iris and implantation and suturing of the TexKPRO. If required a silicone oil endotamponade was placed.
  
  
  RESULTS
  All eyes were stable with the keratoprosthesis. The first prototype showed conjunctival recession on the textile haptics with highly susceptible endopthalmitis risk due to infection of the PVDF so that we decided to remove the prosthesis from all eyes after one case of severe endophthalmitis occurred. The longest time of placement was 40 months and the shortest time 6 months. All eyes were restored by keratoplasty. In animals with the new haptic we found better conjunctivalization and stable implantation of the KPRO.
  
  
  CONCLUSIONS
  The textile KPRO provides a stable implantation procedure and safe connection of fibers to the scleral wound bed. The optical and mechanical implantation is safe and stable. Surface epithelialization is improved with the new surface modifications and different PVDF fiber density but beforel new implantations are planned further conceptual changes will be introduced.
authors.affiliation: Aachener Centrum für Technologietransfer in der Ophthalmologie, Aachen, Deutschland, schrage@acto.de.
authors.forename: N
authors.initials: N
authors.lastname: Schrage
authors.forename: A K
authors.initials: AK
authors.lastname: Cordes
authors.forename: J
authors.initials: J
authors.lastname: Storsberg
authors.forename: S
authors.initials: S
authors.lastname: Sel
authors.forename: H
authors.initials: H
authors.lastname: Röthgen
authors.forename: N
authors.initials: N
authors.lastname: Nass
authors.forename: E
authors.initials: E
authors.lastname: Berndt
authors.forename: S
authors.initials: S
authors.lastname: Jockenhövel
authors.forename: A
authors.initials: A
authors.lastname: Meßner
authors.forename: C
authors.initials: C
authors.lastname: Panfil
mesh_terms: D000818:Animals; D003316:Corneal Diseases / Q000601:surgery*; D016039:Corneal Transplantation / Q000295:instrumentation; D019544:Equipment Failure Analysis; D006801:Humans; D066298:In Vitro Techniques; D011474:Prosthesis Design; D011817:Rabbits; D013526:Surgical Mesh; D013784:Textiles; D016896:Treatment Outcome