title: Trabecular micro-bypass stent implantation during small-incision cataract surgery for open-angle glaucoma or ocular hypertension: Long-term results.
abstract: OBJECTIVE
  To evaluate long-term safety and efficacy of iStent trabecular micro-bypass stent implantation during cataract surgery in patients with primary open-angle, pseudo-exfoliation glaucoma, ocular hypertension, or secondary or post-traumatic glaucoma.
  
  
  METHODS
  AaM Augenklinik am Marienplatz, Munich, Germany.
  
  
  METHODS
  Prospective, open-label, non-randomized study.
  
  
  METHODS
  Preoperative and postoperative evaluations included intra-ocular pressure (IOP), topical ocular hypotensive medication use, cup/disc ratio, corrected-distance visual acuity (CDVA), complications, and adverse events.
  
  
  RESULTS
  A single trabecular micro-bypass stent was implanted through the same temporal, limbal incision used for cataract surgery via phacoemulsification in a consecutive series of 62 eyes of 43 patients. To date, a total of 41 eyes have been followed for 3 years postoperatively, whereas long-term postoperative follow-up on the remaining patients is ongoing. Mean preoperative IOP was 24.1 ± 6.9 mm Hg on a mean of 1.8 medications (±0.9). Analyses of eyes with no secondary surgical intervention showed mean IOP reduction to 14.8 ± 4.2 mm Hg at 12 months (n = 61), 14.5 ± 2.2 mm Hg at 24 months (n = 42), and 14.9 ± 2.3 mm Hg at 36 months (n = 39). Medications were eliminated in 74% of eyes at 36 months. Five eyes, 4 with previous glaucoma surgeries and 1 with pseudo-exfoliation syndrome, required additional glaucoma surgery after stent implantation. No intra-operative or postoperative complications typically seen with conventional glaucoma surgeries occurred after stent implantation. At 36 months, CDVA was 20/40 or better in 38 eyes (93%).
  
  
  CONCLUSIONS
  Trabecular micro-bypass stent implantation during cataract surgery was safe and effective in patients with ocular hypertension or glaucoma as measured by a sustained reduction in IOP and medication use and an excellent safety profile through 3 years after surgery.
  
  
  BACKGROUND
  Dr. Neuhann has no financial or proprietary interest in any material or method mentioned. Glaukos Corp. provided editorial assistance in the preparation of the manuscript.
authors.affiliation: From AaM Augenklinik am Marienplatz, Munich, Germany. Electronic address: tneuhann@web.de.
authors.forename: Tobias H
authors.initials: TH
authors.lastname: Neuhann
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D020327:Glaucoma Drainage Implants; D005902:Glaucoma, Open-Angle / Q000601:surgery*; D006068:Gonioscopy; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D007431:Intraoperative Complications; D019654:Lens Implantation, Intraocular; D008297:Male; D008866:Microsurgery; D008875:Middle Aged; D009798:Ocular Hypertension / Q000601:surgery; D018918:Phacoemulsification; D011183:Postoperative Complications; D011446:Prospective Studies; D019919:Prosthesis Implantation; D015607:Stents; D014065:Tonometry, Ocular; D014129:Trabecular Meshwork / Q000601:surgery*; D014792:Visual Acuity / Q000502:physiology