TY - JOUR
T1 - Randomized, prospective, comparative trial of ex-press glaucoma filtration device versus trabeculectomy (XVT Study)
AU - Netland, Peter A.
AU - Sarkisian, Steven R.
AU - Moster, Marlene R.
AU - Ahmed, Iqbal Ike K.
AU - Condon, Garry
AU - Salim, Sarwat
AU - Sherwood, Mark B.
AU - Siegfried, Carla J.
N1 - Funding Information:
Research support for this investigator-initiated trial was obtained from Optonol Ltd. (Neve Ilan, Israel) and Alcon Laboratories, Inc. (Fort Worth, TX). The sponsors had no role in the design or conduct of this research. Dr Netland received research support from Alcon, SOLX, and New World Medical . Dr Sarkisian received research support from Alcon, Glaukos, Transcend, Aeon Astron ; consulting fees from Alcon, iScience, Ivantis, and Optous; and speaker honoraria from Alcon. Dr Moster received research support from Alcon ; consulting fees from Alcon, Allergan, Merck, BD Medical-Ophthalmic Systems, and iScience; and speaker honoraria from Alcon, Allergan, Merck, iScience, Ista Pharmaceuticals. Dr Ahmed received research support from Alcon, Allergan, AqueSys, Carl Zeiss Meditec, Ivantis, iScience, and Transcend Medical ; consulting fees from AdeTherapeutics, ACE Vision Group, Alcon, Allergan, Aquesys, Carl Zeiss Meditec, Clarity Medical Systems, Ivantis, EndoOptiks, Eyelight, iScience, Glaukos, Ono Pharma, Pfizer, SOLX, Stroma, and Transcend Medical; and speaker honoraria from Alcon, Abbott Medical Optics, Allergan, Carl Zeiss Meditec, Clarity Medical Systems, iScience, and New World Medical. Dr Condon received research support from Alcon ; consulting fees from Alcon and Allergan; and speaker honoraria from Alcon, Allergan, and MST. Dr Salim received research support from Alcon ; and speaker honoraria from Alcon and Merck. Dr. Sherwood received research support from Alcon, BioVascular Inc, and EyeIC ; and consulting fees from Alcon, Allergan, Merck and Sensimed. Dr Siegfried received research support from Alcon . No company wrote or influenced directly the wording of the manuscript. All authors participated in the design and conduct of the study; collection, management, analysis, and interpretation of the data and in the preparation, review and approval of the manuscript. Clinical trial registration ( http://www.clinicaltrials.gov/ ) identifier: NCT00444080 .
PY - 2014/2
Y1 - 2014/2
N2 - Purpose To compare the clinical outcomes of the EX-PRESS glaucoma filtration device placed under a partial-thickness scleral flap with trabeculectomy. Design 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.
AB - Purpose To compare the clinical outcomes of the EX-PRESS glaucoma filtration device placed under a partial-thickness scleral flap with trabeculectomy. Design 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.
UR - https://www.scopus.com/pages/publications/84892610215
U2 - 10.1016/j.ajo.2013.09.014
DO - 10.1016/j.ajo.2013.09.014
M3 - Article
C2 - 24210765
AN - SCOPUS:84892610215
SN - 0002-9394
VL - 157
SP - 433-440.e3
JO - American journal of ophthalmology
JF - American journal of ophthalmology
IS - 2
ER -