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Kathryn B. Freidl, Marlene R. Moster, Shelly R. Gupta, Parul Ichhpujani, Jonathan S. Myers, Michael J. Pro; Efficacy And Safety Of Intracameral TriesenceTm Use In Glaucoma Surgery, An Interim Analysis. Invest. Ophthalmol. Vis. Sci. 2011;52(14):650.
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To evaluate efficacy and safety of intracameral TriesenceTM (Triamcinolone injectable suspension) use in trabeculectomy, tube shunt, or combined phacoemulsification-trabeculectomy.
This is an interim analysis of 53 consecutive, eligible patients enrolled for a randomized clinical trial from April 2009 to December 2010 at Wills Glaucoma Service, Philadelphia. Patients undergoing standard surgical technique were randomized to TriesenceTM or balanced saline solution. They were followed on post-operative day 1 (POD1), week 1, month 1, 3, and 6. Outcome measures were visual acuity (VA), comfort, bleb grading with the Indiana Bleb Appearance Grading Scale (IBAGS), intraocular pressure (IOP), cataract, AC inflammation, and medication use. AC inflammation was assessed at both the slit lamp and with the KOWA FM 500 laser flare meter. Complications were recorded. Success was defined as IOP ≤ 21 mmHg and 20% IOP reduction. Failure was inability to meet above criteria, IOP < 5 mmHg, or the need for repeat glaucoma surgery. The primary outcome (IOP) was analyzed using mixed effects linear regression with fixed effects for treatment arm, time, treatment by time interaction, procedure type, and baseline IOP. A first-order autoregressive covariance structure was assumed to account for correlation among repeated measurements from the same subject. Rates of complications and medication usage were compared using logistic regression. Generalized estimating equation methods were used to account for correlation among repeated measures.
Pre-operative characteristics across arms were similar (age, race, sex, diagnosis, nerve health, cataract, IOP and VA). Mean IOP was higher in the TriesenceTM arm on POD 1. No other significant differences in IOP were observed. Pain and foreign body sensation scores and flare scores were higher in the TriesenceTM arm on Day 1 (p=0.02 and 0.05), while IBAGS H scores were lower (p=0.02). No significant differences at later visits were observed. There were no significant differences in VA, medication need, AC inflammation, or cataract formation. Complication rates were similar, as were surgical success rates at 3 and 6 months.
Although intracameral steroid may add potency and ease compliance, this interim analysis of intracameral TriesenceTM shows neither a difference in AC inflammation, flare, VA, IOP, or comfort compared to controls, nor a difference in cataract, complications or medication need. Intracameral use of TriesenceTM during glaucoma surgery appears safe with similar outcomes to controls.
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