Comparison of 0.1% dexamethasone phosphate eye gel (Dexagel) and 1% prednisolone acetate eye suspension in the treatment of post-operative inflammation after cataract surgery.

UNLABELLED: A prospective, multi-centre, clinical parallel group study was conducted to assess the efficacy and safety of a new 0.1% dexamethasone phosphate eye gel (Group 1, n= 117) compared to 1% prednisolone acetate eye suspension (Group 2I, n=119) in a total of 236 patients (safety population), aged 39-92 years, following cataract surgery. Both drugs were given four times a day for 14 days starting 24+/-4 h after surgery. Criteria for evaluation were the reduction in anterior chamber flare and inflammation severity score (primary efficacy criteria) as well as different secondary efficacy and safety evaluation criteria. Laser photometry (LFM-500, Kowa), slit lamp assessment and the examination of other objective and subjective symptoms of ocular discomfort were performed between the last preoperative and 14th post-operative day. There were no statistically significant differences between the treatment groups concerning primary and secondary efficacy criteria. The mean reduction in anterior chamber flare from day 1 to day 14 post-operatively was 8.34+/-20.80 photons/ms with 0.1% dexamethasone eye gel and 5.72+/-16.70 photons/ms with 1% prednisolone eye suspension. The mean reduction of inflammation severity score was 1.8+/-1.3 points in Group 1 and 2.0+/-1.1 points in Group 2. Intra-ocular pressure did not increase after treatment with 0.1% dexamethasone phosphate eye gel.
CONCLUSION: the results of the study underline the protective effect of topically applied 0.1% dexamethasone phosphate eye gel on the blood-aqueous barrier. This drug is an effective and safe steroidal antiinflammatory agent for topical use following cataract surgery and intraocular lens implantation.

RCT Entities:   Population Interventions Outcomes