Abstract
Purpose:
To test whether subconjunctivally implanted Cyclosporine A affects the incidence and degree of postkeratoplasty corneal neovascularisation.
Methods:
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.
Results:
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).
Conclusions:
Subconjunctival cyclosporine A does not affect postkeratoplasty corneal neovascularisation.
Keywords: 609 neovascularization •
479 cornea: clinical science •
741 transplantation