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To assess the 1-year efficacy and safety of the implantation of two second-generation trabecular micro-bypass stents (iStent Inject®) with concomitant cataract surgery in various subtypes and severities of glaucoma.
This single-surgeon, consecutive case series from a Canadian academic ophthalmology center included subjects with cataract, glaucoma, and the need to reduce intraocular pressure (IOP) and/or medications. The 12-month outcomes included mean IOP and medication burden as well as the proportions of eyes with IOP ≤ 18, ≤ 15, and ≤ 12 mmHg compared to baseline. Other measures included corrected distance visual acuity (CDVA), cup-to-disc ratio (CDR), visual field mean deviation (VF MD), retinal nerve fiber layer (RNFL) thickness, ganglion cell inner plexiform layer (GCIPL) thickness, and adverse events.
In 118 eyes, mean IOP reduced from 17.00 ± 3.82 mmHg preoperatively to 13.97 ± 2.65 mmHg at the 12-month follow-up mark (17.8% reduction, p < 0.001), and mean medication burden decreased from 2.31 ± 1.33 preoperatively to 1.03 ± 1.10 medications (56% reduction, p < 0.001). After 12 months, 93% of eyes achieved IOP ≤ 18 mmHg (versus 69% preoperatively), 70% of eyes achieved IOP ≤ 15 mmHg (versus 42% preoperatively), and 29% of eyes achieved IOP ≤ 12 mmHg (versus 7% preoperatively). For all eyes, topical medications were either maintained or decreased from baseline, with ≥ 1 medication eliminated from the preoperative regimen for 83% of eyes and ≥ 2 medications eliminated for 36% of eyes. Visual acuity improved significantly, consistent with expectations for cataract surgery, while CDR, VF MD, and RNFL and GCIPL thicknesses remained stable. Safety was favorable, with no intraoperative complications and few transient adverse events postoperatively.
iStent Inject implantation with cataract surgery safely reduced IOP and medication burden in a real-world clinical population with mild to severe glaucoma, and stabilized visual field, as well as RNFL and GCIPL thicknesses on OCT.
The Rapid Service Fees were funded by Glaukos Corporation.
Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014;121(11):2081–90. PubMed
Nordstrom BL, Friedman DS, Mozaffari E, Quigley HA, Walker AM. Persistence and adherence with topical glaucoma therapy. Am J Ophthalmol. 2005;140(4):598–606.
Glaucoma Laser Trial Research Group. The Glaucoma Laser Trial (GLT) and glaucoma laser trial follow-up study: 7. Results. Am J Ophthalmol. 1995;120(6):718–31.
Jampel HD, Musch DC, Gillespie BW, Lichter PR, Wright MM, Guire KE, et al. Perioperative complications of trabeculectomy in the Collaborative Initial Glaucoma Treatment Study (CIGTS). Am J Ophthalmol. 2005;140(1):16–22. PubMed
Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE, Group USiS. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011;118(3):459–67. PubMed
Craven ER, Katz LJ, Wells JM, Giamporcaro JE. Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: 2-year follow-up. J Cataract Refract Surg. 2012;38(8):1339–45. PubMed
Arriola-Villalobos P, Martinez-de-la-Casa JM, Diaz-Valle D, Fernandez-Perez C, Garcia-Sanchez J, Garcia-Feijoo J. Combined iStent trabecular micro-bypass stent implantation and phacoemulsification for coexistent open-angle glaucoma and cataract: a long-term study. Br J Ophthalmol. 2012;96(5):645–9.
Katz LJ, Erb C, Carceller Guillamet A, Fea AM, Voskanyan L, Giamporcaro JE, et al. Long-term titrated IOP control with one, two, or three trabecular micro-bypass stents in open-angle glaucoma subjects on topical hypotensive medication: 42-month outcomes. Clin Ophthalmol. 2018;12:255–62. PubMedPubMedCentral
Fea AM, Belda JI, Rekas M, Junemann A, Chang L, Pablo L, et al. Prospective unmasked randomized evaluation of the iStent inject ® versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014;8:875–82.
Klamann MK, Gonnermann J, Pahlitzsch M, Maier AK, Joussen AM, Torun N, et al. iStent inject in phakic open angle glaucoma. Graefes Arch Clin Exp Ophthalmol. 2015;253(6):941–7.
Arriola-Villalobos P, Martinez-de-la-Casa JM, Diaz-Valle D, Morales-Fernandez L, Fernandez-Perez C, Garcia-Feijoo J. Glaukos iStent inject ® trabecular micro-bypass implantation associated with cataract surgery in patients with coexisting cataract and open-angle glaucoma or ocular hypertension: a long-term study. J Ophthalmol. 2016;2016:1056573.
Gonnermann J, Bertelmann E, Pahlitzsch M, Maier-Wenzel AB, Torun N, Klamann MK. Contralateral eye comparison study in MICS & MIGS: Trabectome ® vs. iStent inject ®. Graefes Arch Clin Exp Ophthalmol. 2017;255(2):359–65.
Berdahl J, Voskanyan L, Myers JS, Hornbeak DM, Giamporcaro JE, Katz LJ, et al. Implantation of two second-generation trabecular micro-bypass stents and topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 18-month follow-up. Clin Exp Ophthalmol. 2017;45(8):797–802. PubMedPubMedCentral
Macher T, Haberle H, Wachter J, Thannhauser C, Aurich H, Pham DT. Trabecular microbypass stents as minimally invasive approach after conventional glaucoma filtration surgery. J Cataract Refract Surg. 2018;44(1):50–5. PubMed
Hodapp E, Parrish RK, Anderson DR. Clinical decisions in glaucoma. St. Louis: Mosby Inc; 1993.
Hann CR, Fautsch MP. Preferential fluid flow in the human trabecular meshwork near collector channels. Investig Ophthalmol Vis Sci. 2009;50(4):1692–7.
Saheb H, Ahmed II. Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol. 2012;23(2):96–104. PubMed
Stewart WC, Chorak RP, Hunt HH, Sethuraman G. Factors associated with visual loss in patients with advanced glaucomatous changes in the optic nerve head. Am J Ophthalmol. 1993;116(2):176–81. PubMed
Rossi GC, Pasinetti GM, Scudeller L, Radaelli R, Bianchi PE. Do adherence rates and glaucomatous visual field progression correlate? Eur J Ophthalmol. 2011;21(4):410–4. PubMed
Paula JS, Furtado JM, Santos AS, Coelho Rde M, Rocha EM, Rodrigues Mde L. Risk factors for blindness in patients with open-angle glaucoma followed-up for at least 15 years. Arq Bras Oftalmol. 2012;75(4):243–6. PubMed
Nouri-Mahdavi K, Medeiros FA, Weinreb RN. Fluctuation of intraocular pressure as a predictor of visual field progression. Arch Ophthalmol. 2008;126(8):1168–9 (author reply 1169–70). PubMed
Fechtner RD, Voskanyan L, Vold SD, Tetz M, Auffarth G, Masood I, et al. Five-year, prospective, randomized, multi-surgeon trial of two trabecular bypass stents versus prostaglandin for newly diagnosed open-angle glaucoma. Ophthalmol Glaucoma. 2019;2(3):156–66.
Muniesa MJ, Ezpeleta J, Benitez I. Fluctuations of the intraocular pressure in medically versus surgically treated glaucoma patients by a contact lens sensor. Am J Ophthalmol. 2019;203:1–11. PubMed
Best UP, Domack H, Schmidt V, Khalifa M. Microinvasive glaucoma surgery—efficacy of trabecular stents in combined interventions: a clinical study on 65 eyes. Ophthalmologe. 2019;116(8):771–9. PubMed
Clement CI, Howes F, Ioannidis AS, Shiu M, Manning D. One-year outcomes following implantation of second-generation trabecular micro-bypass stents in conjunction with cataract surgery for various types of glaucoma or ocular hypertension: multicenter, multi-surgeon study. Clin Ophthalmol. 2019;13:491–9. PubMedPubMedCentral
The AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration. Am J Ophthalmol. 2000;130(4):429–40.
Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M, et al. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002;120(10):1268–79. PubMed
Chansangpetch S, Lau K, Perez CI, Nguyen N, Porco TC, Lin SC. Efficacy of cataract surgery with trabecular microbypass stent implantation in combined-mechanism angle closure glaucoma patients. Am J Ophthalmol. 2018;195:191–8. PubMed
Hernstadt DJ, Cheng J, Htoon HM, Sangtam T, Thomas A, Sng CCA. Case series of combined iStent implantation and phacoemulsification in eyes with primary angle closure disease: 1-year outcomes. Adv Ther. 2019;36(4):976–86. PubMed
Robin AL, Covert D. Does adjunctive glaucoma therapy affect adherence to the initial primary therapy? Ophthalmology. 2005;112(5):863–8.
Nelson P, Aspinall P, Papasouliotis O, Worton B, O’Brien C. Quality of life in glaucoma and its relationship with visual function. J Glaucoma. 2003;12(2):139–50. PubMed
Bostan C, Harasymowycz P. Episcleral venous outflow: a potential outcome marker for iStent surgery. J Glaucoma. 2017;26(12):1114–9. PubMed
Fellman RL, Grover DS. Episcleral venous fluid wave: intraoperative evidence for patency of the conventional outflow system. J Glaucoma. 2014;23(6):347–50. PubMed
Samuelson TW, Chang DF, Marquis R, Flowers B, Lim KS, Ahmed IIK, et al. A Schlemm canal microstent for intraocular pressure reduction in primary open-angle glaucoma and cataract: the HORIZON study. Ophthalmology. 2019;126(1):29–37. PubMed
Vold S, Ahmed II, Craven ER, Mattox C, Stamper R, Packer M, et al. Two-year COMPASS trial results: supraciliary microstenting with phacoemulsification in patients with open-angle glaucoma and cataracts. Ophthalmology. 2016;123(10):2103–12. PubMed
- One-Year Outcomes of Second-Generation Trabecular Micro-Bypass Stents (iStent Inject) Implantation with Cataract Surgery in Different Glaucoma Subtypes and Severities
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