PURPOSE: To report 2-year follow-up data after Ahmed valve implantation (New World Medical, Inc) and Molteno single-plate implantation surgical treatment of refractory glaucoma. DESIGN: Prospective, randomized, comparative study. METHODS:Patients with refractory glaucoma, defined as uncontrolled intraocular pressure (IOP) of more than 21 mm Hg despite maximal antiglaucoma medication, previously failed nonseton surgical treatment, or a combination thereof were included. Ninety-two patients were allocated randomly to each of the study groups and underwent implantation of either the Ahmed valve implant (model FP7; 184 mm(2) surface area) or Molteno single-plate implant (134 mm(2) surface area) and were followed up for 24 months. Main outcome measures were IOP and surgical success rate. Other outcome measures were changes in visual acuity, number of ant-glaucoma medications, mean deviation of visual field, and rate of intraoperative and postoperative complications. RESULTS: Those who successfully completed the trial (28 in the Molteno group and 29 in the Ahmed group) achieved significantly less IOP and fewer glaucoma medications, but worse visual acuity 24 months after surgery. The Molteno group, compared with the Ahmed group, achieved significantly lower IOPs after the early postoperative period until the end of the study. Both groups reasonably maintained visual field during the follow-up. The rate of surgical failure was comparable in both groups. Median survival time was 24 months for both groups. There were no devastating intraoperative or postoperative complications in either group. CONCLUSIONS: Both Ahmed and Molteno implants successfully preserved visual field, although IOP control was more pronounced in the Molteno implant group. Copyright 2010 Elsevier Inc. All rights reserved.
RCT Entities:
PURPOSE: To report 2-year follow-up data after Ahmed valve implantation (New World Medical, Inc) and Molteno single-plate implantation surgical treatment of refractory glaucoma. DESIGN: Prospective, randomized, comparative study. METHODS:Patients with refractory glaucoma, defined as uncontrolled intraocular pressure (IOP) of more than 21 mm Hg despite maximal antiglaucoma medication, previously failed nonseton surgical treatment, or a combination thereof were included. Ninety-two patients were allocated randomly to each of the study groups and underwent implantation of either the Ahmed valve implant (model FP7; 184 mm(2) surface area) or Molteno single-plate implant (134 mm(2) surface area) and were followed up for 24 months. Main outcome measures were IOP and surgical success rate. Other outcome measures were changes in visual acuity, number of ant-glaucoma medications, mean deviation of visual field, and rate of intraoperative and postoperative complications. RESULTS: Those who successfully completed the trial (28 in the Molteno group and 29 in the Ahmed group) achieved significantly less IOP and fewer glaucoma medications, but worse visual acuity 24 months after surgery. The Molteno group, compared with the Ahmed group, achieved significantly lower IOPs after the early postoperative period until the end of the study. Both groups reasonably maintained visual field during the follow-up. The rate of surgical failure was comparable in both groups. Median survival time was 24 months for both groups. There were no devastating intraoperative or postoperative complications in either group. CONCLUSIONS: Both Ahmed and Molteno implants successfully preserved visual field, although IOP control was more pronounced in the Molteno implant group. Copyright 2010 Elsevier Inc. All rights reserved.
Authors: Brian A Francis; Rodrigo A B Fernandes; Handan Akil; Vikas Chopra; Bruno Diniz; James Tan; Alex Huang Journal: Graefes Arch Clin Exp Ophthalmol Date: 2017-02-07 Impact factor: 3.117