title: Efficacy of two trabecular micro-bypass stents combined with topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 3-year follow-up.
abstract: OBJECTIVE
  To evaluate the long-term intraocular pressure (IOP)-lowering effect and safety parameters following treatment with two trabecular micro-bypass stents and topical prostaglandin in phakic eyes with open-angle glaucoma (OAG) not controlled on two preoperative medications.
  
  
  METHODS
  This prospective, single-arm, unmasked study enrolled 39 qualified phakic eyes with OAG not controlled on 2 medications, preoperative medicated IOP of 18-30 mmHg, and IOP following medication washout of 22-38 mmHg. Two trabecular micro-bypass stents were implanted as a standalone procedure, and travoprost was started on postoperative day 1. Evaluations included IOP, best-corrected visual acuity, medication use, fundus and slit-lamp examinations, visual field, cup:disc ratio, central corneal thickness, and ocular complications. Data through 18 months were summarized previously. Thirty-seven of the original 39 subjects have been followed for 3 years postoperatively; follow-up is continuing for 5 years.
  
  
  RESULTS
  At 3 years postoperative, 97% of eyes had achieved an IOP reduction of ≥20% from baseline with a reduction of 1 medication. Eighty-six percent of eyes had IOP of ≤18 mmHg with a reduction of 1 medication. Mean medicated IOP decreased to 14.0±2.6 mmHg on 1 medication versus 22.4±2.3 mmHg on 2 medications preoperatively. The mean unmedicated IOP decreased to 17.7±1.7 mmHg at 37 months from 25.3±1.9 mmHg preoperatively. Long-term postoperative adverse events included cataract surgery in 3 eyes due to cataract progression, and trabeculectomy in 1 eye due to uncontrolled IOP of 23 mmHg. No intraoperative or device-related adverse events occurred.
  
  
  CONCLUSIONS
  Significant and sustained reduction in IOP and medications with a favorable safety profile was shown through 3 years after implantation of 2 trabecular micro-bypass stents combined with postoperative travoprost in phakic OAG eyes uncontrolled on 2 preoperative medications. These findings demonstrate the long-term performance and safety of trabecular bypass stents in combination with topical prostaglandin for OAG patients.
authors.affiliation: Altos Eye Physicians, Los Altos, CA.
authors.forename: David F
authors.initials: DF
authors.lastname: Chang
authors.affiliation: Ophthalmic Consultants of Long Island, Rockville Centre, NY.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Donnenfeld
authors.affiliation: Department of Ophthalmology, Wills Eye Hospital, Jefferson Medical College, Philadelphia, PA, USA.
authors.forename: L Jay
authors.initials: LJ
authors.lastname: Katz
authors.affiliation: S.V. Malayan Ophthalmology Centre, Yerevan, Armenia.
authors.forename: Lilit
authors.initials: L
authors.lastname: Voskanyan
authors.affiliation: Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.
authors.forename: Iqbal Ike K
authors.initials: II
authors.lastname: Ahmed
authors.affiliation: Minnesota Eye Consultants, Minneapolis, MN.
authors.forename: Thomas W
authors.initials: TW
authors.lastname: Samuelson
authors.affiliation: Glaukos Corporation, San Clemente, CA.
authors.forename: Jane Ellen
authors.initials: JE
authors.lastname: Giamporcaro
authors.affiliation: Glaukos Corporation, San Clemente, CA.
authors.forename: Dana M
authors.initials: DM
authors.lastname: Hornbeak
authors.affiliation: Carolina Eyecare Physicians, Mount Pleasant, SC, USA.
authors.forename: Kerry D
authors.initials: KD
authors.lastname: Solomon
keywords: IOP; MIGS; glaucoma; medication; trabecular micro-bypass