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
Authors Chang DF, Donnenfeld ED, Katz LJ, Voskanyan L, Ahmed IIK, Samuelson TW, Giamporcaro JE, Hornbeak DM, Solomon KD
Received 30 August 2016
Accepted for publication 17 November 2016
Published 15 March 2017 Volume 2017:11 Pages 523—528
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Lucy Goodman
Peer reviewer comments 2
Editor who approved publication: Dr Scott Fraser
David F Chang,1 Eric D Donnenfeld,2 L Jay Katz,3 Lilit Voskanyan,4 Iqbal Ike K Ahmed,5 Thomas W Samuelson,6 Jane Ellen Giamporcaro,7 Dana M Hornbeak,7 Kerry D Solomon8
1Altos Eye Physicians, Los Altos, CA, 2Ophthalmic Consultants of Long Island, Rockville Centre, NY, 3Department of Ophthalmology, Wills Eye Hospital, Jefferson Medical College, Philadelphia, PA, USA; 4S.V. Malayan Ophthalmology Centre, Yerevan, Armenia; 5Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada; 6Minnesota Eye Consultants, Minneapolis, MN, 7Glaukos Corporation, San Clemente, CA, 8Carolina Eyecare Physicians, Mount Pleasant, SC, USA
Purpose: 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.
Conclusion: 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.
Keywords: glaucoma, trabecular micro-bypass, MIGS, IOP, medication
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