PURPOSE: Ex-PRESS shunt is an alternative filtration procedure to trabeculectomy. This study aimed to compare the 1-year cost differences between the 2 operations.
METHODS: Subjects were enrolled in a randomized controlled trial comparing Ex-PRESS to trabeculectomy. Surgical cost difference and 1-year postoperative costs (follow-up visits, additional procedures, and medications) were determined and compared. The 95% confidence interval of incremental cost-effectiveness ratio was estimated using bootstrap method.
RESULTS: Forty-three subjects with 1-year follow-up were included. Success rate was not significantly different for Ex-PRESS (65%) versus trabeculectomy (55%, P=0.49). Ex-PRESS had a net surgical cost of $956 greater than trabeculectomy. There was no significant difference in the overall postoperative cost [median (interquartile range); $485 (337, 822) vs. $609 (387, 820), P=0.78], cost of follow-up visits [$303 (275, 358) vs. $317 (275, 385), P=0.75], additional procedures [$182 (0, 365) vs. $182 (0, 365), P=0.69], or glaucoma medication [$0 (0, 68) vs. $0 (0, 90), P=0.8] for Ex-PRESS versus trabeculectomy, respectively. The overall 1-year cost was significantly greater for Ex-PRESS and the incremental cost-effectiveness ratio was $9625 (95% confidence interval, $2435-548,084).
CONCLUSIONS: Ex-PRESS is associated with greater surgical cost compared with trabeculectomy. This needs to be considered in conjunction with efficacy and safety if Ex-PRESS is to supersede trabeculectomy.
PURPOSE: To compare the efficacy and safety of the Ex-PRESS glaucoma shunt with standard trabeculectomy.
PATIENTS AND METHODS: Consenting patients with medically uncontrolled open-angle glaucoma were prospectively randomized to trabeculectomy or Ex-PRESS shunt both with mitomycin-C. Exclusion criteria included previous ocular surgery with the exception of clear cornea phaco or 1 previous trabeculectomy, uveitis, and vitreous in the anterior chamber. Standardized data collection sheets were completed at baseline and postoperative day 1, weeks 1 and 2, and months 1, 2, 3, 6, and 12. Primary outcome was intraocular pressure (IOP). Complete success was defined as an IOP between 5 and 18 mm Hg and a 20% reduction from baseline without medication. A sample size calculation determined that 52 eyes were required to detect a 2.0 mm Hg IOP difference with a power of 80%.
RESULTS: Sixty-four subjects were enrolled, 33 in the Ex-PRESS and 31 in the trabeculectomy group. IOP was not statistically significantly different between groups. Baseline and 1-year mean IOP was 22.0±6.8 versus 22.7±10.3 mm Hg (P=0.76) and 11.6±4.5 versus 11.3±4.5 mm Hg (P=0.81) in the trabeculectomy versus Ex-PRESS groups, respectively. Complete success was 57% versus 70% (P=0.28) in the trabeculectomy versus Ex-PRESS groups, respectively. There were no statistically significant differences in surgical time, number of glaucoma medications, visual acuity, central corneal thickness, endothelial cell counts, complications, interventions, or bleb morphology between the trabeculectomy and the Ex-PRESS groups.
CONCLUSIONS: There was no statistically significant difference between the trabeculectomy and Ex-PRESS groups regarding IOP, success rates, complications, additional interventions, and bleb morphology.
PURPOSE:: To compare the rate of visual recovery after Ex-PRESS implantation versus standard trabeculectomy.
PATIENTS AND METHODS:: Subjects enrolled in a prospective randomized controlled trial comparing Ex-PRESS to trabeculectomy were analyzed for postoperative changes in visual acuity (VA). Risk factors for visual loss (split fixation, cup-disc ratio, intraocular pressure, visual field mean deviation, and hypotony) were evaluated.
RESULTS:: Sixty-four subjects were enrolled (33 Ex-PRESS, 31 trabeculectomy). There was no significant difference in mean logMAR VA between groups at baseline or any study visit. VA was significantly reduced up to week 2 following surgery in both the groups. However, by month 1, VA in the Ex-PRESS group was no longer significantly different from baseline (P=0.23) and remained nonsignificant at subsequent visits up to 6 months. In the trabeculectomy group, VA remained significantly lower than baseline at each study visit. At 6 months, 47% of the trabeculectomy eyes compared with 16% of the Ex-PRESS eyes had lost ≥2 Snellen lines (P=0.01). Reasons for VA loss included cataract, central retinal vein occlusion, and diabetic retinopathy, however, in a significant number of cases no cause could be determined. None of the risk factors evaluated were associated with vision loss.
CONCLUSIONS:: Although there was no difference in mean VA between the Ex-PRESS and trabeculectomy groups at any time point, trabeculectomy eyes were more likely to lose ≥2 Snellen lines. In addition, VA recovered faster in the Ex-PRESS group.
