title: Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up.
abstract: The study objective was to evaluate the intraocular pressure (IOP) and medication-lowering effect of 2 second-generation trabecular micro-bypass stents in eyes with open-angle glaucoma (OAG) on one preoperative medication.
  
  
  
  Fifty-seven qualified phakic eyes with OAG on 1 medication, preoperative medicated IOP of 18-30 mmHg, and preoperative unmedicated (post-washout) IOP of 22-38 mmHg underwent implantation of 2 second-generation trabecular micro-bypass stents in a standalone procedure. Evaluations included IOP, best-corrected visual acuity, medication use, fundus and slit lamp examinations, visual field, cup to disc ratio, pachymetry, and complications and interventions. Subjects have been followed for 18 months, and follow-up is ongoing.
  
  
  
  At Month 12 postoperative, 100% of eyes had achieved an IOP reduction ≥20% (100% had IOP ≤18 mmHg and 67% had IOP ≤15 mmHg) without medication versus preoperative unmedicated IOP, and 75% had IOP reduction ≥20% without medication versus preoperative medicated IOP. The Month 12 mean unmedicated IOP had decreased by 42%, to 14.2 ± 1.9 mmHg vs 24.4 ± 1.3 mmHg preoperatively, and this reduction was maintained through 18 months (14.4 ± 2.1 mmHg). A high safety profile was observed.
  
  
  
  In this prospective, open-label, single-arm study, the standalone implantation of two second-generation trabecular micro-bypass stents in OAG patients on 1 preoperative medication resulted in IOP reduction to ≤15 mmHg and elimination of medication through 18 months, with favorable safety.
  
  
  
  ClinicalTrials.gov identifier, NCT02868190.
  
  
  
  Glaukos Corporation, San Clemente, CA.
authors.affiliation: Minnesota Eye Consultants, Minneapolis, MN, USA. rllindstrom@mneye.com.
authors.forename: Richard
authors.initials: R
authors.lastname: Lindstrom
authors.affiliation: Sacramento Eye Consultants, Sacramento, CA, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Lewis
authors.affiliation: Glaukos Corporation, San Clemente, CA, USA.
authors.forename: Dana M
authors.initials: DM
authors.lastname: Hornbeak
authors.affiliation: S.V. Malayan Ophthalmology Centre, Yerevan, Armenia.
authors.forename: Lilit
authors.initials: L
authors.lastname: Voskanyan
authors.affiliation: Glaukos Corporation, San Clemente, CA, USA.
authors.forename: Jane Ellen
authors.initials: JE
authors.lastname: Giamporcaro
authors.affiliation: Harvard Eye Associates, Laguna Hills, CA, USA.
authors.forename: John
authors.initials: J
authors.lastname: Hovanesian
authors.affiliation: Dean A. McGee Eye Institute, University of Oklahoma Health Science Center, Oklahoma City, OK, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Sarkisian
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000175:diagnosis / Q000188:drug therapy / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000175:diagnosis / Q000209:etiology; D011446:Prospective Studies; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D015607:Stents; D014065:Tonometry, Ocular / Q000379:methods; D016896:Treatment Outcome; D014792:Visual Acuity / Q000187:drug effects
chemical_list: D000959:Antihypertensive Agents
keywords: Glaucoma; IOP; MIGS; Medication; Ophthalmology; Trabecular micro-bypass