April 2010
Volume 51, Issue 13
ARVO Annual Meeting Abstract  |   April 2010
Biosynthetic Corneas - 2 Years After Implantation in Humans
Author Affiliations & Notes
  • P. Fagerholm
    Dept of Ophthal, Linkoping University, Linkoping, Sweden
  • N. Lagali
    Dept of Ophthal, Linkoping University, Linkoping, Sweden
  • W. B. Jacksson
    University of Ottawa, Eye Institute, Ottawa, Ontario, Canada
  • M. Griffith
    Dept of Ophthal, Linkoping University, Linkoping, Sweden
  • Footnotes
    Commercial Relationships  P. Fagerholm, None; N. Lagali, None; W.B. Jacksson, None; M. Griffith, Patents, P.
  • Footnotes
    Support  VR 2005-3522-27546-49
Investigative Ophthalmology & Visual Science April 2010, Vol.51, 1153. doi:
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    • Get Citation

      P. Fagerholm, N. Lagali, W. B. Jacksson, M. Griffith; Biosynthetic Corneas - 2 Years After Implantation in Humans. Invest. Ophthalmol. Vis. Sci. 2010;51(13):1153.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : To evaluate biosynthetic corneas as substitutes for donor corneas in humans.

Methods: : Recombinant human collagen type III was cross-linked to fabricate corneal substitutes. Following proper study approval, a Phase I study was initiated. 10 patients , scheduled for corneal grafting, were enrolled. Nine had keratoconus and one a deep scar following Pseudomonas keratitis.Lamellar surgery was performed. Three overlying sutures were used to anchor the graft. Topical dexametasone and chloramphenicol was given postoperatively. The sutures were removed after 6 weeks.The patients were followed clinically and evaluated for UCVA, BSCVA and BCLVA. Sensitivity (Cochet-Bonnet) and Shirmer were tested. Photography, OCT (Visante), topography and IVCM was used to document the healing

Results: : After 3 months all patients had epithelialized and implants were anchored by keratocyte ingrowth. The mean BSCVA at 6 months (20/133) improved slightly at 18 months (20/80). The mean BCLCVA was 20/50 at 12 months and was better in younger patients (mean of 20/40 in the 5 youngest). One patient had BCLVA of 20/20 at 12 months.The corneal thickness was stable between 3 and 18 months at about 400 µm. The Shirmer values were 20 ± 10 mm in operated eyes and 17 ± 8 mm in fellow eyes. At 18 months the sensitivity was 37 mm in operated eyes and 60 mm in fellow eyes. IVCM documented quantitatively an increase in nerve in-growth at the sub-basal epithelium.

Conclusions: : Bioengineered corneal substitutes are compatible and promote regeneration of corneal cells. They show stability after 2-3 months. The results after 2 years will be presented.

Clinical Trial: : EudraCT 2006-006585-42

Keywords: cornea: clinical science • clinical (human) or epidemiologic studies: outcomes/complications • wound healing 

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