CLINICAL TRIAL: Treatment of Posterior Uveitis With a Fluocinolone Acetonide Implant: Three-Year Clinical Trial Results Callanan, D. G., Jaffe, G. J., Martin, D. F., Pearson, P. A., Comstock, T. L. Mon, 08 Sep 2008 00:00:00 -0000
Objectives To evaluate the safety and efficacy of 0.59-mg and 2.1-mg fluocinolone acetonide (FA) intravitreous implants in noninfectious posterior uveitis.
Design A 3-year, multicenter, randomized, historically controlled trial of the 0.59-mg FA intravitreous implant in 110 patients and the 2.1-mg FA intravitreous implant in 168 patients.
Main Outcome Measures Recurrence rate, vision, and complications.
Results Uveitis recurrence was reduced in implanted eyes from 62% (during the 1-year preimplantation period) to 4%, 10%, and 20% during the 1-, 2-, and 3-year postimplantation periods, respectively, for the 0.59-mg dose group (P < .01) and from 58% to 7%, 17%, and 41%, respectively, for the 2.1-mg dose group (P < .01). More implanted eyes than nonimplanted eyes had improved visual acuity (P < .01). Implanted eyes had higher incidences of intraocular pressure elevation (≥ 10 mm Hg) than nonimplanted eyes (P < .01), and glaucoma surgery was required in 40% of implanted eyes vs 2% of nonimplanted eyes (P < .01). Cataracts were extracted in 93% of phakic implanted eyes vs 20% of phakic nonimplanted eyes (P < .01).
Conclusions The FA implant significantly reduced uveitis recurrence and improved or stabilized visual acuity in subjects with noninfectious posterior uveitis. Most subjects required cataract extraction, and a significant proportion required intraocular pressure–lowering surgery.
Application to Clinical Practice The FA implant provides an alternative therapy for prolonged control of inflammation in noninfectious posterior uveitis.
Trial Registration clinicaltrials.gov Identifier: NCT00407082
CLINICAL TRIAL: Topical Ketorolac in Vitreoretinal Surgery: A Prospective, Randomized, Placebo-Controlled, Double-Masked Trial Kim, S. J., Lo, W. R., Hubbard, G. B., Srivastava, S. K., Denny, J. P., Martin, D. F., Yan, J., Bergstrom, C. S., Cribbs, B. E., Schwent, B. J., Aaberg, T. M. Mon, 08 Sep 2008 00:00:00 -0000
Objective To evaluate the effects of topical ketorolac in patients undergoing vitreoretinal surgery.
Methods One hundred nine patients undergoing vitrectomies were randomized to receive either topical ketorolac tromethamine, 0.4%, or placebo. Patients were instructed to begin taking the study medication 3 days preoperatively (4 times daily) and to continue taking it 4 weeks postoperatively.
Main Outcome Measures Intraoperative pupil diameter, postoperative day 1 pain and inflammation, 1-month postoperative retinal thickness, and preoperative and 1-month postoperative best-corrected visual acuities.
Results The difference in mean pupil diameters between patients using ketorolac and those taking placebo was 0.06 mm (P = .39). Patients taking ketorolac and those taking placebo had mean pain scores (scale, 1-10) of 0.24 (SD, 0.6) and 1.06 (SD, 2) (P = .03) and mean inflammation grades (grade, 0-4) of 0.59 (SD, 0.7) and 1.16 (SD, 0.9) (P < .001), respectively. Ketorolac reduced central subfield thickness by 8%, but this was not statistically significant. At 1 month, mean visual acuities improved to 0.40 logMAR units (mean Snellen, 20/50; SD, 0.28 logMAR units) in the ketorolac group from 0.83 logMAR units (20/150+2; SD, 0.60 logMAR units) at baseline and to 0.67 logMAR units (20/100+1; SD, 0.46 logMAR units) in the placebo group from 0.92 logMAR units (20/150–2; SD, 0.62 logMAR units) at baseline (P = .001).
Conclusions Topical ketorolac was well tolerated and safe, reduced postoperative pain and inflammation, and improved visual recovery in this prospective, double-masked trial.
Application to Clinical Practice Topical ketorolac may benefit patients undergoing vitreoretinal surgery.
Trial Registration clinicaltrials.gov Identifier: NCT00576329
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