Abstract
Purpose:
To evaluate the efficacy and safety of intracameral Triesence™ (Triamcinolone injectable suspension) use in trabeculectomy, tube shunt, or combined phacoemulsification-trabeculectomy.
Methods:
This is an analysis of 77 consecutive, eligible patients enrolled for a randomized clinical trial from April 2009 to July 2011 at the Wills Glaucoma Service, Philadelphia. Patients undergoing standard surgical technique were randomized to Triesence™ 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 ≤ 21mmHg and 20% IOP reduction. Failure was inability to meet above criteria, IOP < 5mmHg, or the need for repeat glaucoma surgery. Mixed effects linear regression with square root transformation to meet assumptions of normality and constant variance was used for the IOP and other outcomes.
Results:
There were no significant differences between treatment groups on any of the patient characteristics (age, race, sex, diagnosis, nerve health, cataract, IOP and VA). Mean IOP was higher in the Triesence™ arm on Day 1, but this difference did not reach statistical significance. No significant differences in IOP were observed at any time points between the groups. Among the outcome measures recorded, dry eye scores were lower in the Triesence™ arm at Month 1 while flare scores were higher in the Triesence™ arm on Day 1 but lower at Month 1. No other significant differences in outcome measures were observed. The rate of complications was higher in the Triesence™ arm on Day 1. There were no significant differences in medication use between the two groups.
Conclusions:
Intracameral Triesence™ use showed no difference at 6 months in AC inflammation, flare, VA, IOP, or comfort when compared to controls. There were no differences in cataract, complications beyond day 1, or medications needed. This study found no evidence to support the use of Triesence™ in routine glaucoma surgeries such as trabeculectomy, tube shunt, or other combined procedures.
Keywords: 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials •
568 intraocular pressure •
557 inflammation