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D. Yuen, Y. Buys, Y. Jin, T. Alasbali, M. Smith, G. Trope; A Pilot Prospective Study Comparing the Effect of Corticosteroids versus NSAIDS on the Hypertensive Phase Following Ahmed Glaucoma Valve Surgery. Invest. Ophthalmol. Vis. Sci. 2010;51(13):4441.
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To compare the effect of topical steroids versus NSAIDs on the hypertensive phase (HP) following Ahmed Glaucoma Valve (AGV) surgery. We hypothesized that the use of topical NSAIDs would reduce the incidence and severity of the HP. A demonstration of this may support a potential paradigm shift in the first choice of topical anti-inflammatory utilized after AGV surgery.
Prospective, randomized, double-masked controlled trial. 28 consecutive consenting patients were randomized to receive either topical dexamethasone or ketorolac. Total follow-up time was three months. The main outcome measure was incidence and severity of the HP. HP was defined as IOP >21 mmHg after initial post-operative reduction to <22 mmHg. Post-surgical complication was one of the secondary outcome measures.
4 patients (31%) in the ketorolac arm versus 8 patients (53%) in the dexamethasone arm exhibited the HP (P=0.276). The incidence of the HP in the ketorolac arm versus the dexamethasone arm respectively was as follows: nil for both groups at week one; nil versus 4/15 (27%) at week two (P=0.106); 1/13 (8%) versus 2/11 (18%) at week four (P=0.576); 2/11 (18%) versus 2/9 (22%) at week six to eight (P=0.100); 1/10 (10%) versus nil at week ten to twelve (P=1.000). The severity of the HP, as determined by the mean IOP at the appearance of the HP, was 25.8 ± 3.5 versus 26.4 ± 8.9 mmHg in the ketorolac and dexamethasone groups respectively (P=0.897). The mean time to appearance of the HP was 6.3 ± 1.5 weeks in the ketorolac arm versus 3.8 ± 2.2 weeks in the dexamethasone arm (P=0.069). Wound leak was the most severe complication and there were 3 cases (23%) in the ketorolac group versus nil in the steroid group (P=0.087). Conjunctival retraction was observed in 8 patients (62%) in the ketorolac arm versus 2 patients (13%) in the dexamethasone arm (P=0.016).
The incidence and severity of the HP was greater at all time periods in the steroid group especially at weeks 2, 4 and 10-12 but the data points were not statistically significant between the two groups at all time points. Based upon the sample size utilized in this study, we are not able to confirm if steroids are responsible for the HP. A multi-centered trial is needed for sufficient numbers to confirm the clinical trend. The NSAID group demonstrated greater wound healing problems and further investigation into the safety of NSAID use post-AGV surgery is recommended.
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