Clinical Ophthalmology (Sep 2022)

Multicenter Effectiveness and Disease Stability Through 3 Years After iStentTrabecular Micro-Bypass with Phacoemulsification in Glaucoma and Ocular Hypertension

  • Clement C,
  • Howes F,
  • Ioannidis A,
  • Shiu M,
  • Manning D,
  • Lusthaus JA,
  • Skalicky SE,
  • Goodwin TW

Journal volume & issue
Vol. Volume 16
pp. 2955 – 2968

Abstract

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Colin Clement,1– 4 Frank Howes,5 Alexandros Ioannidis,6 Michael Shiu,7 David Manning,8 Jed A Lusthaus,3,4,9 Simon E Skalicky,10 Todd W Goodwin11 1Eye Associates, Sydney, NSW, Australia; 2Fairfield Eye Surgery, Fairfield, NSW, Australia; 3Glaucoma Unit, Sydney Eye Hospital, Sydney, NSW, Australia; 4Discipline of Ophthalmology, The University of Sydney, Sydney, NSW, Australia; 5Eye & Laser Centre, Gold Coast, QLD, Australia; 6Vision Eye Institute, Melbourne, VIC, Australia; 7Laser Sight Centre, Melbourne, VIC, Australia; 8Hunter Cataract & Eye Centre, Charlestown, NSW, Australia; 9Eyehaus, Sydney, NSW, Australia; 10Department of Surgery Ophthalmology, University of Melbourne, Melbourne, VIC, Australia; 11NQ Eye Specialists, Currajong, QLD, AustraliaCorrespondence: Colin Clement, Eye Associates, Level 4, 187 Macquarie Street, Sydney, NSW, 2000, Australia, Tel +612 9247 9972, Email [email protected]: To evaluate 3-year safety and efficacy of two second-generation trabecular micro-bypass stents. (iStent inject®) with phacoemulsification.Materials and Methods: This multicenter retrospective study of iStent inject implantation with phacoemulsification included data from eight surgeons across Australia. Eyes with cataract and mild to advanced glaucoma [predominantly primary open-angle (POAG), primary angle closure (PAC), or normal-tension (NTG) glaucoma] or ocular hypertension (OHT) were included. Study assessments included intraocular pressure (IOP); number of ocular hypotensive medications; proportions of eyes with 0, 1, 2, or ≥ 3 IOP-lowering medications; IOP ≤ 15 mmHg or ≤ 18 mmHg; visual fields (VF); retinal nerve fiber layer thickness (RNFL); central corneal thickness (CCT); intraoperative complications; adverse events; and secondary surgeries.Results: A total of 273 eyes underwent surgery and had 36-month follow-up. At 36 months versus preoperative, mean IOP decreased by 15.5% (16.4± 4.6 mmHg to 13.9± 3.5 mmHg; p< 0.001), and 70.3% of eyes achieved IOP of ≤ 15 mmHg (versus 49.1% preoperatively; p< 0.001). The mean medication burden decreased by 68.5% (from 1.51± 1.17 to 0.48± 0.89 medications; p< 0.001); 71.4% of eyes were medication-free (versus 21.6% preoperatively; p< 0.001), while 6.2% of eyes were on ≥ 3 medications (versus 22.3% preoperatively; p< 0.001); 96.3% of eyes maintained or reduced medications vs preoperative. Significant IOP and medication reductions occurred across glaucoma subtypes (POAG, PAC, NTG, OHT): 13– 22% for IOP (p< 0.05 for all) and 42– 94% for medication (p< 0.05 for all). Favorable safety included few adverse events; stable VF, RNFL, and CCT; and filtering surgery in only 8 eyes (2.9%) over 3 years.Conclusion: In this multicenter cohort from 8 surgeons across Australia, significant IOP and medication reductions were sustained through 3 years after iStent inject implantation with phacoemulsification. Results were favorable across different glaucoma subtypes (including POAG, PAC, NTG, OHT), severities, and surgeons, thereby underscoring the real-world relevance and efficacy of iStent inject implantation for glaucoma treatment.Keywords: microinvasive glaucoma surgery, MIGS, glaucoma, iStent inject, intraocular pressure, second generation, multicenter

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