Abstract
To report 1-year treatment outcomes of P50 EX-PRESS implant versus nonpenetrating deep sclerectomy (NPDS) with Esnoper V2000 combined with phacoemulsification. Randomized, prospective and multicentre clinical trial. Settings: Six clinical centres. Patients 54-89years of age without previous filtering surgery with cataract and glaucoma who required lower levels of intraocular pressure (IOP). Phaco-EX-PRESS P50 or Phaco-NPDS with Esnoper V2000, both groups with mitomycin C (0.2mg/ml for 2min). IOP, complete success rate (IOP: ≥6 and ≤18mmHg), visual acuity, use of medical therapy and systematic assessment of complications and postoperative interventions. A total of 98 eyes were enrolled, including 50 in the EX-PRESS group and 48 in the NPDS group. At 12months, IOP (mean±SD) was 13.9±3.3mmHg in EX-PRESS group and 13.3±3.6mmHg 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±13.6min in EX-PRESS group and 63.3±19.4min in NPDS group (p=0.01). Phaco-EX-PRESS surgery had similar success rate compared to Phaco-NPDS during 1year of follow-up. Both procedures were associated with similar IOP reduction and use of additional medical therapy at 12months. EX-PRESS surgery required more postoperative interventions and had more complications, but needed less surgical time compared to NPDS.
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