title: Randomized, prospective, comparative trial of EX-PRESS glaucoma filtration device versus trabeculectomy (XVT study).
abstract: OBJECTIVE
  To compare the clinical outcomes of the EX-PRESS glaucoma filtration device placed under a partial-thickness scleral flap with trabeculectomy.
  
  
  METHODS
  Randomized, prospective, multicenter trial.
  
  
  METHODS
  A total of 120 eyes in 120 subjects were analyzed, including 59 eyes treated with EX-PRESS and 61 eyes treated with trabeculectomy. Both the EX-PRESS and the trabeculectomy groups were treated intraoperatively with mitomycin C and followed postoperatively for 2 years. Surgical success was defined as 5 mm Hg ≤ intraocular pressure ≤ 18 mm Hg, with or without medications, without further glaucoma surgery.
  
  
  RESULTS
  Mean intraocular pressure was significantly reduced compared with baseline in both groups (P < 0.001). Average intraocular pressure and number of medications were similar in both groups during follow-up, with mean intraocular pressure at 2 years after surgery of 14.7 ± 4.6 mm Hg and 14.6 ± 7.1 mm Hg in the EX-PRESS and trabeculectomy groups, respectively (P = 0.927). At 2 years after surgery, the success rate was 83% and 79% in the EX-PRESS and trabeculectomy groups, respectively (P = 0.563). Although visual acuity (logMAR) was significantly decreased on day 1 in both groups, the vision was not significantly different compared with baseline at 1 month after EX-PRESS implant (P = 0.285) and 3 months after trabeculectomy (P = 0.255). The variance of early postoperative intraocular pressure values was similar between groups on the first postoperative day but higher after trabeculectomy compared with EX-PRESS implant on day 7 (P = 0.003). The total number of postoperative complications was higher after trabeculectomy than after EX-PRESS implantation (P = 0.013).
  
  
  CONCLUSIONS
  Mean intraocular pressures, medication use, and surgical success were similar at 2 years after treatment with the EX-PRESS device and trabeculectomy. Vision recovery between groups was also similar throughout the study, although return to baseline vision was more rapid in the EX-PRESS group. Intraocular pressure variation was lower during the early postoperative period, and postoperative complications were less common after EX-PRESS implantation compared with trabeculectomy.
authors.affiliation: University of Virginia School of Medicine, Charlottesville, Virginia. Electronic address: pnetland@virginia.edu.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Netland
authors.affiliation: Dean McGee Eye Institute, University of Oklahoma, Oklahoma City, Oklahoma.
authors.forename: Steven R
authors.initials: SR
authors.lastname: Sarkisian
authors.affiliation: Wills Eye Hospital, Philadelphia, Pennsylvania.
authors.forename: Marlene R
authors.initials: MR
authors.lastname: Moster
authors.affiliation: University of Toronto, Toronto, Ontario.
authors.forename: Iqbal Ike K
authors.initials: II
authors.lastname: Ahmed
authors.affiliation: Allegheny General Hospital, Pittsburgh, Pennsylvania.
authors.forename: Garry
authors.initials: G
authors.lastname: Condon
authors.affiliation: Hamilton Eye Institute, University of Tennessee, Memphis, Tennesee.
authors.forename: Sarwat
authors.initials: S
authors.lastname: Salim
authors.affiliation: University of Florida, Gainesville, Florida.
authors.forename: Mark B
authors.initials: MB
authors.lastname: Sherwood
authors.affiliation: Washington University, St. Louis, Missouri.
authors.forename: Carla J
authors.initials: CJ
authors.lastname: Siegfried
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000477:Alkylating Agents / Q000008:administration & dosage; D000959:Antihypertensive Agents / Q000008:administration & dosage; D005260:Female; D005901:Glaucoma / Q000601:surgery*; D020327:Glaucoma Drainage Implants; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects / Q000502:physiology; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D011183:Postoperative Complications; D011446:Prospective Studies; D013524:Surgical Flaps; D014065:Tonometry, Ocular; D014130:Trabeculectomy; D016896:Treatment Outcome
chemical_list: D000477:Alkylating Agents; D000959:Antihypertensive Agents; D016685:Mitomycin