Purpose: To compare the inflammatory response after phacoemulsification and intraocular lens implantation, using postoperative treatment with 0.5% prednisolone acetate eye drops or vehicle.
Design: A multi-center randomized double-masked vehicle-controlled, parallel group phase IV study.
Methods: Sixty-two eyes of 62 patients undergoing phacoemulsification were examined at five German university eye hospitals (Mainz, Heidelberg, Bonn, Erlangen, Frankfurt/Main). Patients received either 0.5% prednisolone acetate eye drops (group 1) or vehicle eye drop solution (group 2) four times a day until day 2, then open-label treatment with 0.5% prednisolone acetate eye drops four times a day continued until day 14 for all patients. Postoperative inflammation was evaluated by using laser flare photometry. Secondary efficacy variables included visual acuity, intraocular pressure, corneal edema, bulbar conjunctival hyperemia and ocular discomfort.
Results: In group 1, median flare rose from 7.4 photon counts/ms preoperatively to 31.0 photon counts/ms at day 1. In group 2, the flare increased from 8.6 photon counts/ms preoperatively to 30.5 photon counts/ms at day 1. The differences between the groups were not statistically significant. At day 3, flare measures were reduced in group 1 but remained fairly unchanged in group 2 (20.8 photon counts/ms vs 32.6 photon counts/ms), which was statistically significant (p = 0.0055). At day 14, photon counts were comparable in both groups (13.0 photon counts/ms vs 11.4 photon counts/ms), respectively. Both groups were comparable regarding secondary efficacy variables.
Conclusions: 0.5% prednisolone acetate appeared to be significantly more effective as vehicle in controlling intraocular inflammation after phacoemulsification; both groups had a similar safety profile.