PURPOSE: To compare the safety and efficacy of the Surodex dexamethasone anterior segment drug delivery system (Oculex Pharmaceuticals, Inc.) and dexamethasone 0.1% eyedrops (Maxidex) in patients with inflammation after cataract surgery. SETTING:Cataract Service, Department of Ophthalmology, Lothian University Hospitals, Edinburgh, United Kingdom. METHODS: This comparative single-masked parallel-group study comprised 1 eye of 19 patients having phacoemulsification cataract extraction and posterior chamber intraocular lens implantation. The Surodex group had the dexamethasone drug delivery system inserted into the anterior chamber (AC) angle during surgery and was treated with saline eyedrops (Isopto Plain) for 4 weeks. The control group had no drug delivery system or a placebo inserted at surgery and were treated with dexamethasone 0.1% eyedrops for 4 weeks. A Kowa FM-500 laser flare meter was used to objectively measure AC flare, the main outcome measure. Slitlamp biomicroscopy to grade AC flare and cells, intraocular pressure measurement, and corneal endothelial specular microscopy, performed up to 60 days after surgery, were the secondary outcome measures. The Surodex group had safety follow-ups after completion of the initial study period. RESULTS: Both groups had a steady increase in laser flare meter readings postoperatively. The readings peaked at 3 days in the control group and at 7 days in the Surodex group. This was followed by a gradual decline toward baseline values up to 28 days, after which the values remained at a similar level to 60 days in both groups. There were no significant differences in flare meter readings between the groups throughout the study. There were also no significant between-group differences in subjective assessment of intraocular inflammation and in impact on corneal endothelial cell count (P =.67). Surodex remnants persisted up to a mean of 22.0 months +/- 2.5 (SD) postoperatively in 6 eyes (54%). Neither group had a severe adverse event. CONCLUSION: Surodex appeared to be as effective as dexamethasone 0.1% eyedrops in controlling intraocular inflammation after cataract surgery by phacoemulsification, and both methods had a similar safety profile.
RCT Entities:
PURPOSE: To compare the safety and efficacy of the Surodexdexamethasone anterior segment drug delivery system (Oculex Pharmaceuticals, Inc.) and dexamethasone 0.1% eyedrops (Maxidex) in patients with inflammation after cataract surgery. SETTING:Cataract Service, Department of Ophthalmology, Lothian University Hospitals, Edinburgh, United Kingdom. METHODS: This comparative single-masked parallel-group study comprised 1 eye of 19 patients having phacoemulsification cataract extraction and posterior chamber intraocular lens implantation. The Surodex group had the dexamethasone drug delivery system inserted into the anterior chamber (AC) angle during surgery and was treated with saline eyedrops (Isopto Plain) for 4 weeks. The control group had no drug delivery system or a placebo inserted at surgery and were treated with dexamethasone 0.1% eyedrops for 4 weeks. A Kowa FM-500 laser flare meter was used to objectively measure AC flare, the main outcome measure. Slitlamp biomicroscopy to grade AC flare and cells, intraocular pressure measurement, and corneal endothelial specular microscopy, performed up to 60 days after surgery, were the secondary outcome measures. The Surodex group had safety follow-ups after completion of the initial study period. RESULTS: Both groups had a steady increase in laser flare meter readings postoperatively. The readings peaked at 3 days in the control group and at 7 days in the Surodex group. This was followed by a gradual decline toward baseline values up to 28 days, after which the values remained at a similar level to 60 days in both groups. There were no significant differences in flare meter readings between the groups throughout the study. There were also no significant between-group differences in subjective assessment of intraocular inflammation and in impact on corneal endothelial cell count (P =.67). Surodex remnants persisted up to a mean of 22.0 months +/- 2.5 (SD) postoperatively in 6 eyes (54%). Neither group had a severe adverse event. CONCLUSION:Surodex appeared to be as effective as dexamethasone 0.1% eyedrops in controlling intraocular inflammation after cataract surgery by phacoemulsification, and both methods had a similar safety profile.
Authors: Diane T W Chang; Michael C Herceg; Richard A Bilonick; Larissa Camejo; Joel S Schuman; Robert J Noecker Journal: Clin Ophthalmol Date: 2009-06-02