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Randomized Controlled Trial
. 2012 May;26(5):703-10.
doi: 10.1038/eye.2012.13. Epub 2012 Feb 17.

Comparison of trabeculectomy and Ex-PRESS implantation in fellow eyes of the same patient: a prospective, randomised study

E Dahan  1 , G J Ben Simon, A Lafuma
Affiliations
Randomized Controlled Trial

Comparison of trabeculectomy and Ex-PRESS implantation in fellow eyes of the same patient: a prospective, randomised study

E Dahan et al. Eye (Lond). 2012 May.

Abstract

Purpose: To compare intraocular pressure (IOP) over time after standard trabeculectomy vs Ex-PRESS implantation in patients with bilateral primary open-angle glaucoma (POAG).

Design: Prospective, randomised study.

Patients and methods: This study included adult patients with bilateral POAG necessitating surgery. Each patient underwent trabeculectomy in one eye and Ex-PRESS implantation under a scleral flap in the other eye according to randomised contralateral allocations. Efficacy was assessed by IOP values and success rates (IOP threshold and/or need for topical glaucoma medication) during 30 months. Statistical analysis included Generalised Estimate Equation and Cox Survival models, and paired t-tests.

Results: Thirty eyes of 15 patients were studied for a mean of 23.6 months (SD, ± 6.9). At the last follow-up visit, mean pre-operative IOP decreased from 31.1 (± 14.2) to 16.2 (± 1.5) mm Hg after trabeculectomy, and from 28.1 (± 9.0) to 15.7 (± 1.8) mm Hg after Ex-PRESS implantation (P=0.001). The mean number of anti-glaucoma medicines prescribed at the last follow-up decreased from 3.7 pre-operatively (both groups) to 0.9 after trabeculectomy vs 0.3 after Ex-PRESS implantation (P=0.001). Complete success rates (5<IOP<18 mm Hg without medications) were higher with Ex-PRESS compared with trabeculectomy (P=0.0024). Postoperative complications were more frequent after trabeculectomy (33%) compared with Ex-PRESS (20%), with four trabeculectomy eyes (27%) needing postoperative interventions, compared with none with Ex-PRESS.

Conclusions: Trabeculectomy and Ex-PRESS implantation provided similar IOP control, but the Ex-PRESS group had a lower rate of complications, fewer postoperative interventions, and needed less glaucoma medications.

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Figures

Figure 1
Figure 1
IOP (mm Hg) and number of glaucoma medicines over time according to surgical technique.
Figure 2
Figure 2
Time trend of the average difference in IOP between Ex-PRESS vs trabeculectomy eyes from 1 month after surgery to the end of follow-up (30 months). Note: For all time points in which the 95% CI (grey shaded zone) of the average difference in IOP between Ex-PRESS vs trabeculectomy eyes lies below the dashed line (difference in IOP=0), Ex-PRESS eyes had a significantly lower (better) IOP.
Figure 3
Figure 3
Survival curve with complete success defined as 5P=0.0024).
Figure 4
Figure 4
Survival curve with qualified success defined as 5P=0.0124).
See this image and copyright information in PMC

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