title: Gold Micro-Shunt Implants Versus Ahmed Glaucoma Valve: Long-term Outcomes of a Prospective Randomized Clinical Trial.
abstract: OBJECTIVE
  To compare long-term outcomes of Ahmed glaucoma valve (AGV), 24 μm Gold Micro-Shunt (GMS), and 48 μm GMS implantation for treatment of refractory glaucoma.
  
  
  METHODS
  This was a 3-armed randomized interventional prospective clinical trial. Within an institutional setting, 29 adults (29 eyes) with refractory glaucoma [mean baseline intraocular pressure (IOP) ≥ 22 mm Hg on maximal medication, status post at least 1 failed trabeculectomy, defined visual field defect, and without recent glaucoma-related surgery] were randomly assigned to AGV, 24 μm GMS, or 48 μm GMS implantation. Exclusion criteria included uveitic, traumatic, or neovascular glaucoma. The 3 groups were comparatively evaluated preoperatively and 1, 2, 3, and 5 years postoperatively for IOP and numbers of glaucoma medications needed. Main outcome measures were implant survival rates. Results of the 24 and 48 μm GMS groups were also compared separately.
  
  
  RESULTS
  In all groups the final IOP (in mm Hg) was significantly lower than the preoperative IOP (17.3 ± 2.6 vs. 33.5 ± 6.7, P=0.004; 17.8 ± 2.4 vs. 25.7 ± 0.7, P=0.0001; and 19.6 ± 5.2 vs. 35.6 ± 2.2, P=0.0001 in the AGV, 24 μm GMS, and 48 μm GMS groups, respectively). Differences between initial and final mean numbers of medications were not significant. Cumulative probabilities of success at 5 years were 77.8%, 77.8%, and 72.7%, respectively.
  
  
  CONCLUSIONS
  During long-term follow-up, success rates in the 2 GMS groups and the AGV group were similar. Likewise, IOP reduction and the need for continued glaucoma medical therapy remained high and were similar for all devices.
authors.affiliation: *Department of Ophthalmology, The Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer †Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Alon
authors.initials: A
authors.lastname: Skaat
authors.forename: Oded
authors.initials: O
authors.lastname: Sagiv
authors.forename: Michael
authors.initials: M
authors.lastname: Kinori
authors.forename: Guy J
authors.initials: GJ
authors.lastname: Ben Simon
authors.forename: Modi
authors.initials: M
authors.lastname: Goldenfeld
authors.forename: Shlomo
authors.initials: S
authors.lastname: Melamed
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D017889:Exfoliation Syndrome / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D020327:Glaucoma Drainage Implants; D005902:Glaucoma, Open-Angle / Q000503:physiopathology / Q000601:surgery*; D006046:Gold; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D011183:Postoperative Complications; D011446:Prospective Studies; D019919:Prosthesis Implantation; D014065:Tonometry, Ocular; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
chemical_list: D006046:Gold