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Claus Cursiefen, Thomas Reinhard, Felix Bock, Hans-Ulrich Prokosch; Subconjunctival Cyclosporine A implants do not affect corneal neovascularisation after transplantation: results of a randomized clinical trial. Invest. Ophthalmol. Vis. Sci. 2013;54(15):2090.
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To test whether subconjunctivally implanted Cyclosporine A affects the incidence and degree of postkeratoplasty corneal neovascularisation.
Prospective, randomized, controlled phase II/III clinical trial comprising trial sites in Germany, India and the USA. Overall, 97 enrolled patients were randomized to receive either two dosages of subconjunctival Cyclosporine A implants (A: 36 and B: 40) or placebo (n=21) at time of penetrating keratoplasty. The incidence and degree of postkeratoplasty corneal neovascularisation were evaluated (LX201-01 study). A web-based image upload system was developed. Quantitative and objetive evaluation of standardized digital slit lamp pictures was performed using AnlysisB morphometry sofware.
No significant difference in the incidence and the degree of corneal neovascularisation was found between treatment groups and placebo group. Mean neovascularisation was 3.2% ± 0.3 in treatment A versus placebo (3.5% ± 0.27; p= 0.5) and 3.0% ± 0.4 and in treatment B versus placebo (3.5% ± 0.27; p= 0.3).
Subconjunctival cyclosporine A does not affect postkeratoplasty corneal neovascularisation.
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