Abstract
Purpose
To report the efficacy, safety profile, and postoperative management of XEN45 implant at 12-month follow-up.
Patients and methods
This was a retrospective, non-randomised interventional case series involving patients who underwent XEN45 implantation by a single, experienced glaucoma specialist in a tertiary centre. Primary outcome measures were the intraocular pressure (IOP) and the number of medications at 1-year follow-up visit. Two IOP criteria were chosen to measure success: IOP ≤21 mm Hg and ≥20% reduction from baseline (criteria one); and IOP ≤15 mm Hg and ≥30% reduction from baseline (criteria two).
Results
All 39 eyes completed 1-year follow-up. The mean preoperative IOP was 24.9±7.8 mm Hg on three drops, which reduced to 14.5±3.4 mm Hg at month 12 (P<0.005) on 0.7 drops (P<0.005). On the basis of criteria one, the cumulative probability of success at 1 year was 87.0% without medication and 92.0% with medication. On the basis of criteria two, cumulative probability of success was 62.0% without medication and 64.0% with medication. Bleb intervention with a median of 2 (range 1–4) was required for 51.3% of eyes. Implant was obstructed by iris tissue in three eyes (7.7%); one eye (2.6%) developed hyphaema; eight eyes (20.5%) had numerical hypotony (IOP≤5 mm Hg) at day 1, of which all spontaneously resolved by week 4 apart from one eye.
Conclusions
The XEN45 implant proved to be an effective treatment with a good safety profile at 1-year follow-up period. The high rate of postoperative bleb intervention does not make XEN45 a ‘fit-and-forget’ procedure and therefore the procedure should ideally be performed by surgeons experienced in bleb management.
Similar content being viewed by others
Log in or create a free account to read this content
Gain free access to this article, as well as selected content from this journal and more on nature.com
or
References
Manasses DT, Au L . The new era of glaucoma micro-stent surgery. Ophthalmol Ther 2016; 5 (2): 135–146.
Craven ER, Katz LJ, Wells JM, Giamporcaro JE, Group iS. Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up. J Cataract Refract Surg 2012; 38 (8): 1339–1345.
Arriola-Villalobos P, Martínez-de-la-Casa JM, Díaz-Valle D, Fernández-Pérez C, García-Sánchez J, García-Feijoó 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): 645–649.
Tan SZ, Au L . Manchester iStent study: 3-year results and cost analysis. Eye (Lond) 2016; 30 (10): 1365–1370.
Pfeiffer N, Garcia-Feijoo J, Martinez-de-la-Casa JM, Larrosa JM, Fea A, Lemij H et al. A randomized trial of a Schlemm's canal microstent with phacoemulsification for reducing intraocular pressure in open-angle glaucoma. Ophthalmology 2015; 122 (7): 1283–1293.
Hoeh H, Ahmed II, Grisanti S, Grabner G, Nguyen QH, Rau M et al. Early postoperative safety and surgical outcomes after implantation of a suprachoroidal micro-stent for the treatment of open-angle glaucoma concomitant with cataract surgery. J Cataract Refract Surg 2013; 39 (3): 431–437.
Kirwan JF, Lockwood AJ, Shah P, Macleod A, Broadway DC, King AJ et al. Trabeculectomy in the 21st century: a multicenter analysis. Ophthalmology 2013; 120 (12): 2532–2539.
Katz LJ, Erb C, Carceller GA, Fea AM, Voskanyan L, Wells JM et al. Prospective, randomized study of one, two, or three trabecular bypass stents in open-angle glaucoma subjects on topical hypotensive medication. Clin Ophthalmol 2015; 9: 2313–2320.
Ahuja Y, Ma Khin Pyi S, Malihi M, Hodge DO, Sit AJ . Clinical results of ab interno trabeculotomy using the trabectome for open-angle glaucoma: the Mayo Clinic series in Rochester, Minnesota. Am J Ophthalmol 2013; 156 (5): 927–935.e922.
Pérez-Torregrosa VT, Olate-Pérez Á, Cerdà-Ibáñez M, Gargallo-Benedicto A, Osorio-Alayo V, Barreiro-Rego A et al. Combined phacoemulsification and XEN45 surgery from a temporal approach and 2 incisions. Arch Soc Esp Oftalmol 2016; 91 (9): 415–421.
Buchacra O, Duch S, Milla E, Stirbu O . One-year analysis of the iStent trabecular microbypass in secondary glaucoma. Clin Ophthalmol 2011; 5: 321–326.
Grisanti S, Margolina E, Hoeh H, Rau M, Erb C, Kersten-Gomez I et al. [Supraciliary microstent for open-angle glaucoma: clinical results of a prospective multicenter study]. Ophthalmologe 2014; 111 (6): 548–552.
Gandolfi SA, Ungaro N, Ghirardini S, Tardini MG, Mora P . Comparison of Surgical outcomes between canaloplasty and Schlemm's canal scaffold at 24 months' follow-up. J Ophthalmol 2016; 2016: 3410469.
Edmunds B, Thompson JR, Salmon JF, Wormald RP . The National Survey of Trabeculectomy. II. Variations in operative technique and outcome. Eye (Lond) 2001; 15 (Pt 4): 441–448.
Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL et al. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol 2012; 153 (5): 789–803. e782.
Edmunds B, Thompson JR, Salmon JF, Wormald RP . The National Survey of Trabeculectomy. III. Early and late complications. Eye (Lond) 2002; 16 (3): 297–303.
Spiegel D, García-Feijoó J, García-Sánchez J, Lamielle H . Coexistent primary open-angle glaucoma and cataract: preliminary analysis of treatment by cataract surgery and the iStent trabecular micro-bypass stent. Adv Ther 2008; 25 (5): 453–464.
Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC et al. Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol 2012; 153 (5): 804–814.e801.
Patel I, de Klerk TA, Au L . Manchester iStent study: early results from a prospective UK case series. Clin Experiment Ophthalmol 2013; 41 (7): 648–652.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Competing interests
LA has received research support, honorarium, and travel reimbursement from Glaukos, Aquesys/Allergan, Ivantis, Eyetech care, Thea, and Alcon Pharmaceuticals. The remaining authors declare no conflict of interest.
Rights and permissions
About this article
Cite this article
Tan, S., Walkden, A. & Au, L. One-year result of XEN45 implant for glaucoma: efficacy, safety, and postoperative management. Eye 32, 324–332 (2018). https://doi.org/10.1038/eye.2017.162
Received:
Accepted:
Published:
Issue date:
DOI: https://doi.org/10.1038/eye.2017.162
This article is cited by
-
Management of fracture and displacement of a previously successful bilateral transconjunctival ab-externo XEN gel stent: a case report
BMC Ophthalmology (2025)
-
A review of the application of in-vivo confocal microscopy on conjunctival diseases
Eye and Vision (2024)
-
Five-year outcomes of ab interno Xen 45 gel stent implantation
Graefe's Archive for Clinical and Experimental Ophthalmology (2024)
-
XEN®-45 implantation for refractory uveitic glaucoma
Graefe's Archive for Clinical and Experimental Ophthalmology (2024)
-
Recanalization of Xen45 gel stent implant occlusion using 10 − 0 nylon suture in refractory glaucoma: a case report
BMC Ophthalmology (2023)
