Resumen:
Purpose To report 1-year treatment outcomes of P50 EX-PRESS implant versus nonpenetrating deep sclerectomy (NPDS) with Esnoper V2000 combined with phacoemulsification. Design Randomized, prospective and multicentre clinical trial. Methods Settings: Six clinical centres. Population: Patients 54-89 years of age without previous filtering surgery with cataract and glaucoma who required lower levels of intraocular pressure (IOP). Interventions: Phaco-EX-PRESS P50 or Phaco-NPDS with Esnoper V2000, both groups with mitomycin C (0.2 mg/ml for 2 min). Main outcome measures: IOP, complete success rate (IOP: >= 6 and <= 18 mmHg), visual acuity, use of medical therapy and systematic assessment of complications and postoperative interventions. Results A total of 98 eyes were enrolled, including 50 in the EX-PRESS group and 48 in the NPDS group. At 12 months, IOP (mean +/- SD) was 13.9 +/- 3.3 mmHg in EX-PRESS group and 13.3 +/- 3.6 mmHg in NPDS group (p = 0.38). Success rate was 75% and 80% in EX-PRESS and NPDS groups, respectively (p = 0.53). The number of glaucoma medications (mean +/- SD) was 0.2 +/- 0.55 in EX-PRESS group and 0.17 +/- 0.44 in NPDS group (p = 1.00). The total number of complications was 66 in 35 subjects in EX-PRESS group and 39 in 23 subjects in NPDS group (p = 0.02). The incidence of more than one complication was n = 13 (26%) versus n = 9 (18.8%) in EX-PRESS and NPDS groups, respectively (p = 0.38). The total number of required postoperative interventions was 59 and 26 in EX-PRESS and NPDS groups, respectively (p = 0.01). Visual acuity was similar in both groups at month 12 (p = 0.13). Surgical time (mean +/- SD) was 52.6 +/- 13.6 min in EX-PRESS group and 63.3 +/- 19.4 min in NPDS group (p = 0.01). Conclusion Phaco-EX-PRESS surgery had similar success rate compared to Phaco-NPDS during 1 year of follow-up. Both procedures were associated with similar IOP reduction and use of additional medical therapy at 12 months. EX-PRESS surgery required more postoperative interventions and had more complications, but needed less surgical time compared to NPDS.
