title: 3D Corneal Shape After Implantation of a Biosynthetic Corneal Stromal Substitute.
abstract: The current and projected shortage of transplantable human donor corneas has prompted the development of long-term alternatives to human donor tissue for corneal replacement. The biosynthetic stromal substitutes (BSS) characterized herein represent a potentially safe alternative to donor organ transplantation for anterior corneal stromal diseases. The goal of this phase 1 safety study was to characterize the three-dimensional (3D) corneal shape of the first 10 human patients implanted with a BSS and assess its stability over time.
  
  
  
  Ten patients underwent anterior lamellar keratoplasty using a biosynthetic corneal stromal implant for either advanced keratoconus or central corneal scarring. Surgeries were performed at Linköping University Hospital, between October and November 2007. Serial corneal topographies were performed on all eyes up to a 4-year follow-up when possible. Three-dimensional shape average maps were constructed for the 10 BSS corneas and for 10 healthy controls. Average 3D shape corneal elevation maps, difference maps, and statistics maps were generated.
  
  
  
  The biosynthetic stromal substitutes implants remained stably integrated into the host corneas over the 4-year follow-up period, without signs of wound dehiscence or implant extrusion. The biosynthetic stromal substitutes corneas showed steeper surface curvatures and were more irregular than the healthy controls.
  
  
  
  Corneal astigmatism and surface steepness were observed 4 years after BSS implantation, while the implants remained stably integrated in the host corneas. Future studies will indicate if biomaterials technology will allow for the optimization of postoperative surface irregularity after anterior stromal replacement, a new window of opportunity that is not available with traditional corneal transplantation techniques.
authors.affiliation: Maisonneuve-Rosemont Hospital Research Center, Montreal, Quebec, Canada 2Department of Ophthalmology, University of Montreal, Montreal, Quebec, Canada.
authors.forename: Jeb A
authors.initials: JA
authors.lastname: Ong
authors.affiliation: Department of Computer Science and Operations Research, University of Montreal, Montreal, Quebec, Canada.
authors.forename: Edouard
authors.initials: E
authors.lastname: Auvinet
authors.affiliation: Maisonneuve-Rosemont Hospital Research Center, Montreal, Quebec, Canada.
authors.forename: Karolyn J
authors.initials: KJ
authors.lastname: Forget
authors.affiliation: Integrative Regenerative Medicine Centre, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.
authors.forename: Neil
authors.initials: N
authors.lastname: Lagali
authors.affiliation: Integrative Regenerative Medicine Centre, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.
authors.forename: Per
authors.initials: P
authors.lastname: Fagerholm
authors.affiliation: Maisonneuve-Rosemont Hospital Research Center, Montreal, Quebec, Canada 4Integrative Regenerative Medicine Centre, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.
authors.forename: May
authors.initials: M
authors.lastname: Griffith
authors.affiliation: Department of Ophthalmology, University of Montreal, Montreal, Quebec, Canada 3Department of Computer Science and Operations Research, University of Montreal, Montreal, Quebec, Canada.
authors.forename: Jean
authors.initials: J
authors.lastname: Meunier
authors.affiliation: Maisonneuve-Rosemont Hospital Research Center, Montreal, Quebec, Canada 2Department of Ophthalmology, University of Montreal, Montreal, Quebec, Canada.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Brunette
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003315:Cornea / Q000473:pathology* / Q000601:surgery; D003319:Corneal Stroma / Q000473:pathology / Q000637:transplantation*; D019781:Corneal Topography / Q000379:methods*; D016039:Corneal Transplantation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D021621:Imaging, Three-Dimensional; D007640:Keratoconus / Q000175:diagnosis / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011184:Postoperative Period; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014792:Visual Acuity; D055815:Young Adult