Phacotrabeculectomy versus Phaco with Implantation of the Ex-PRESS Device: Surgical and Refractive Outcomes-A Randomized Controlled Trial.

The aim of this study was to compare surgical and refractive outcomes between phacotrabeculectomy (P-Trab) and phaco with Ex-PRESS (P-Ex-PRESS) for glaucoma at a 6-month follow-up. This prospective randomized controlled trial included 81 eyes; 43 eyes (53%) and 38 eyes (47%) were assigned to the P-Ex-PRESS and P-Trab groups, respectively. Refraction, intraocular pressure (IOP), and best-corrected visual acuity were measured. Refractive change was analyzed using the cylinder's magnitude, and polar analysis assessed the change in the trend of astigmatism [with-the-rule, against-the-rule (ATR), oblique (OBL)], evaluating mean astigmatism in centroid form. All patients showed a statistically significant postoperative decrease in IOP (P < 0.05). There were no differences between the groups in terms of postoperative IOP and visual outcomes or in astigmatism preoperatively or postoperatively (P = 0.61, P = 0.74). In both groups, the mean preoperative and postoperative astigmatism were ATR and OBL, respectively. Preoperative and postoperative centroids in the P-Ex-PRESS group were 0.44 ± 1.32 D at 177° and 0.35 ± 1 D at 8°, respectively, (P = 0.5) and in the P-Trab group were 0.16 ± 1.5 D at 141° and 0.39 ± 1.38 D at 29°, respectively (P = 0.38). Both P-Ex-PRESS and P-Trab showed comparable antihypertensive efficacy in treating open-angle glaucoma over 6 months. Preoperative and postoperative astigmatism did not differ between groups. The groups showed comparable results for final visual acuity.

RCT Entities:   Population Interventions Outcomes