| Donnenfeld, 2011 |
Experimental (n=52): difluprednate 0.05%, On the day of surgery (day 0): 1 drop every 15 min during the hour before arrival to the surgery centre. On arrival, staff-administered 1 drop every 15 min (three drops total). After surgery, a single drop was instilled immediately on entry to surgical recovery, another drop was administered while in surgical recovery, and a final drop was given on leaving surgical recovery. After discharge, 1 drop of medication every 2 hours for the remainder of day 0. Starting on the day after surgery (day 1), four times a day for 1 week and two times per day for the subsequent week.
Control(n=52): prednisolone acetate 1%, following the same schedule described above.
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Primary: change from baseline in corneal thickness at day 1.
Secondary: corneal thickness at day 15±2 days and at day 30±3 days; UCVA at all time points; BCVA at all time points; corneal oedema (epithelial and stromal) at all time points; endothelial cell counts at day 30±3 days; OCT-CRT at day 15±2 days and at day 30±3 days; and IOP at all time points.
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| Gundakalle, 201314
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Primary: the proportion of patients with an mRS Score of 3–6 at 1 year.
Secondary: results based on actual treatment as opposed to the primary intent-to-treat analysis and separate evaluation of patients’ crossing over from their assigned group to the alternative treatment group.
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| Devi 201413
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Primary: effectiveness (clearing of inflammation) at day 14: AC cells, AC flare, chemosis, ocular pain and visual acuity.
Secondary: Effectiveness and safety at days 0, 1, 7, 28 and 35. Safety measures were IOP and any AEs.
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| Garg 201611
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Experimental (n=50): 0.05% difluprednate ophthalmic emulsion drops, six times a day for 4 weeks.
Control (n=50): prednisolone acetate 1% ophthalmic suspension drops, six times a day for 4 weeks.
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Primary: Effectiveness of the drug on day 1, first week, second week, fourth week with following parameters: ocular pain, anterior chamber reaction in the form of aqueous cells and flare and final visual acuity.
Secondary: Safety and adverse events (including IOP changes).
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| Manna 201612
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Experimental (n=200): Difluprednate 0.05% ophthalmic emulsion, starting 24 hours after surgery: 1 drop four times a day for 2 weeks, then 1 drop two times per day for 1 week, then one drop once a day for 1 week.
Control (n=200): Prednisolone acetate 1% ophthalmic suspension, starting 24 hours after surgery: 1 drop eight times a day for 1 week, then 1 drop six times a day for 1 week, then 1 drop four times a day for 1 week, then 1 drop two times per day for 1 week.
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Primary: Effectiveness measured at day 1, first week, second week and fourth week after surgery. Measure of effectiveness were AC cells and flare.
Secondary: Safety assessed at 6 weeks after the surgery via BCVA and IOP.
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| Wilson 2016 |
Experimental (n=39): difluprednate 0.05% (durezol ophthalmic emulsion, Alcon Laboratories, Fort Worth, Texas, USA). Dosing regimen was: day 0 one drop, then four times a day for 14 days, then tapering for 14 days according to investigator's assessment.
Control (n=40): prednisolone acetate 1% (PredForte ophthalmic suspension, Allergan, Irvine, California, USA). The same dosing regimen as the experimental arm was applied.
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Primary: Safety assessed via IOP changes and any other AEs at days 0, 1, 8 (±1 day) and 15 (±2 days), and at the end of study (day 29±2 days).
Secondary: Effectiveness evaluated at days 0, 1, 8 (±1 day) and 15 (±2 days), and at the end of study (day 29±2 days). Measures of effectiveness were number and percentage of patients with an anterior cell grade of 0 (no cells) at the end of the 14day treatment period (day 15±2 days) as a primary end point, and at other time points as secondary measures.
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