Purpose: To report the efficacy of the XEN45 implant in advanced to end-stage glaucoma patients, after a 6 months follow-up.
Methods: Retrospective, noncomparative electronic health record audit of patients who had undergone an XEN45 procedure. The main outcome measures were intraocular pressure (IOP) reduction and the number of antihypertensive medications. Secondary outcome measures were the rates of early postoperative complications. Complete and qualified success; failure and hypotony were defined according to the World Glaucoma Association guidelines (Shaarawy TM et al.). Needling rates and short-term complications were assessed and a subgroup analysis was performed.
Results: A total of 39 eyes with advanced to end stage-glaucoma were included. Twenty eyes (51%) had undergone combined cataract surgery and 19 (49%), the XEN45 procedure alone. Mean IOP decreased from 19.67 ± 7.87 mm Hg to 13.18 ± 6.09 mm Hg; the number of medications decreased from a median use of 4 (IQR 2–5) to 0 (IQR 0–1). Complete success was achieved in 24 (61.5%) of the eyes, qualified success in 10 (25.6%), and failure in five (12.82%). Needling was required in 15 (38.46%) of the eyes at 6 months. Choroidal detachment occurred in eight (20.51%) eyes, numerical hypotony (IOP ≤ 5 mm Hg) at day 1 was noted in seven (17.95%) eyes with a full resolution by 2 weeks.
Conclusion: In this short-term follow-up, we have seen that XEN45 is a viable, effective, and safe procedure utilized in advanced to end-stage glaucoma patients. Treating cases of significant hypotony using AC reformation with sulfur hexafluoride (SF6) is a safe and effective procedure.
Tham Y-C, Li X, Wong TY, et al. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology 2014;121(11):2081–2090. DOI: 10.1016/j.ophtha.2014.05.013
Kidd MN, O'Connor M. Progression of field loss after trabeculectomy: a five-year follow-up. Br J Ophthalmol 1985;69(11):827–831. DOI: 10.1136/bjo.69.11.827
Heijl A, Leske MC, Bengtsson B, et al. Reduction of intraocular pressure and glaucoma progression: results from the early manifest glaucoma trial. Arch Ophthalmol 2002;120(10): 1268–1279. DOI: 10.1001/archopht.120.10.1268
Saheb H, Ahmed IIK. Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol 2012;23(2):96–104. DOI: 10.1097/ICU.0b013e32834ff1e7
Ansari E. An update on implants for minimally invasive glaucoma surgery (MIGS). Ophthalmol Ther 2017;6(2):233–241. DOI: 10.1007/s40123-017-0098-2
Manasses DT, Au L. The new era of glaucoma micro-stent surgery. Ophthalmol Ther 2016;5(2):135–146. DOI: 10.1007/s40123-016-0054-6
Sheybani A, Reitsamer H, Ahmed IIK. Fluid dynamics of a novel micro-fistula implant for the surgical treatment of glaucoma. Invest Ophthalmol Vis Sci 2015;56(8):4789–4795. DOI: 10.1167/iovs.15-16625
Tan SZ, Walkden A, Au L. One-year result of XEN45 implant for glaucoma: efficacy, safety, and postoperative management. Eye (Lond) 2018;32(2):324–332. DOI: 10.1038/eye.2017.162
Gregorio AD, Pedrotti E, Russo L, et al. Minimally invasive combined glaucoma and cataract surgery: clinical results of the smallest ab interno gel stent. Int Ophthalmol 2018;38(3):1129–1134. DOI: 10.1007/s10792-017-0571-x
Pérez-Torregrosa VT, Olate-Pérez Á, Cerdà-Ibáñez M, et al. Combined phacoemulsification and XEN45 surgery from a temporal approach and 2 incisions. Arch Soc Esp Oftalmol 2016;91(9):415–421. DOI: 10.1016/j.oftal.2016.02.006
Heidinger A, Schwab C, Lindner E, et al. A retrospective study of 199 xen45 stent implantations from 2014 to 2016. J Glaucoma 2019;28(1):75–79. DOI: 10.1097/IJG.0000000000001122
Galal A, Bilgic A, Eltanamly R, et al. XEN glaucoma implant with Mitomycin C 1-year follow-up: result and complications. J Ophthalmol 2017;2017:5457246. DOI: 10.1155/2017/5457246
Mansouri K, Guidotti J, Rao HL, et al. Prospective evaluation of standalone XEN gel implant and combined phacoemulsification-xen gel implant surgery: 1-year results. J Glaucoma 2018;27(2):140–147. DOI: 10.1097/IJG.0000000000000858
Karimi A, Lindfield D, Turnbull A, et al. A multi-centre interventional case series of 259 ab-interno Xen gel implants for glaucoma, with and without combined cataract surgery. Eye (Lond) 2019;33(3):469–477. DOI: 10.1038/s41433-018-0243-8
Reitsamer H, Sng C, Vera V, et al. Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma. Graefes Arch Clin Exp Ophthalmol 2019;257(5):983–996. DOI: 10.1007/s00417-019-04251-z
Fea AM, Bron AM, Economou MA, et al. European study of the efficacy of a cross-linked gel stent for the treatment of glaucoma. J Cataract Refract Surg 2020;46(3):441–450. DOI: 10.1097/j.jcrs.0000000000000065
Shaarawy TM, Sherwood MB, Grehn F. Guidelines on design and reporting of glaucoma surgical trials. World Glaucoma Association 2009:15–24.
Laborda-Guirao T, Cubero-Parra JM, Hidalgo-Torres A. Efficacy and safety of XEN 45 gel stent alone or in combination with phacoemulsification in advanced open angle glaucoma patients: 1-year retrospective study. Int J Ophthalmol 2020;13:1250–1256. DOI: 10.18240/ijo.2020.08.11
Hodapp E, Parrish RK II, Anderson DR: Clinical Decisions in Glaucoma. St. Louis, CV Mosby, 1993.
Widder RA, Dietlein TS, Dinslage S, et al. The XEN45 gel stent as a minimally invasive procedure in glaucoma surgery: success rates, risk profile, and rates of re-surgery after 261 surgeries. Graefes Arch Clin Exp Ophthalmol 2018;256(4):765–771. DOI: 10.1007/s00417-018-3899-7
Smith M, Charles R, Abdel-Hay A, et al. 1-year outcomes of the Xen45 glaucoma implant. Eye (Lond) 2019;33(5):761–766. DOI: 10.1038/s41433-018-0310-1
Sheybani A, Dick HB, Ahmed IIK. Early clinical results of a novel ab interno gel stent for the surgical treatment of open-angle glaucoma. J Glaucoma 2016;25(7):e691–e696. DOI: 10.1097/IJG.0000000000000352
Gedde SJ, Schiffman JC, Feuer WJ, et al. Treatment outcomes in the tube versus trabeculectomy study after one year of follow-up. Am J Ophthalmol 2007;143(1):9–22. DOI: 10.1016/j.ajo.2006.07.020
Wilson MR, Mendis U, Smith SD, et al. Ahmed glaucoma valve implant vs trabeculectomy in the surgical treatment of glaucoma: a randomized clinical trial. Am J Ophthalmol 2000;130(3):267–273. DOI: 10.1016/s0002-9394(00)00473-6
Dar N, Sharon T, Hecht I, et al. Efficacy and safety of the ab interno gelatin stent in severe pseudoexfoliation glaucoma compared to non-pseudoexfoliation glaucoma at 6 months. Eur J Ophthalmol 2020;30(5):1028–1033. DOI: 10.1177/1120672119848277
Kalina AG, Kalina PH, Brown MM. XEN® gel stent in medically refractory open-angle glaucoma: results and observations after one year of use in the United States. Ophthalmol Ther 2019;8(3):435–446. DOI: 10.1007/s40123-019-0192-8
Hengerer FH, Kohnen T, Mueller M, et al. Ab interno gel implant for the treatment of glaucoma patients with or without prior glaucoma surgery: 1-year results. J Glaucoma 2017;26(12):1130–1136. DOI: 10.1097/IJG.0000000000000803
Grover DS, Flynn WJ, Bashford KP, et al. Performance and safety of a new ab interno gelatin stent in refractory glaucoma at 12 months. Am J Ophthalmol 2017;183:25–36. DOI: 10.1016/j.ajo.2017.07.023
Fea AM, Spinetta R, Cannizzo PML, et al. Evaluation of bleb morphology and reduction in IOP and glaucoma medication following implantation of a novel gel stent. J Ophthalmol 2017;2017:9364910. DOI: 10.1155/2017/9364910
Schlenker MB, Gulamhusein H, Conrad-Hengerer I, et al. Efficacy, safety, and risk factors for failure of standalone ab interno gelatin microstent implantation versus standalone trabeculectomy. Ophthalmology 2017;124(11):1579–1588. DOI: 10.1016/j.ophtha.2017.05.004