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