Skip to main content

Advertisement

Log in

Results of fluorouracil-augmented Xen45 implantation in primary open-angle and pseudoexfoliation glaucoma

  • Original Paper
  • Published:
International Ophthalmology Aims and scope Submit manuscript

Abstract

Purpose

To report the effectiveness and safety of 5-fluorouracil (5-FU)-augmented Xen45 implantation in primary open-angle glaucoma (POAG) and pseudoexfoliation glaucoma (PEXG).

Methods

This single-center, retrospective chart review study included 29 eyes that underwent 5-FU-augmented Xen45 implantation. Main outcome measures were intraocular pressure (IOP) levels and number of glaucoma medications. Surgical success was defined as IOP ≤ 21 mmHg and ≥ 20% reduction from preoperative levels without (complete success) or with (qualified success) glaucoma medications and without further glaucoma surgery at last follow-up. All postoperative interventions and complications were also noted.

Results

The mean age of the patients was 67.5 ± 10.3 years, and the mean follow-up time was 23.2 ± 12.6 months. Mean IOP was 24.5 ± 8.7 mmHg and decreased by 30.2% at 12 months, 24.9% at 24 months, and 31.7% at final visit (p < 0.001, p = 0.006, p > 0.001, respectively). Mean number of glaucoma medications decreased from 2.83 preoperatively to 0.71 at 12 months, 0.87 at 24 months, and 0.86 at final visit (p < 0.001). At final visit, the complete success rate was 48.3%, qualified success rate was 69%, and 62.1% of the eyes were free of glaucoma medications. Needling was performed in 7 eyes (24%). Adverse events included choroidal detachment in 5 eyes, hyphema in 2 eyes, and endophthalmitis in 1 eye.

Conclusion

5-FU-augmented Xen45 implantation in POAG and PEXG patients provided safe and effective IOP lowering with significant reduction of glaucoma medications up to 3 years.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Gedde SJ, Herndon LW, Brandt JD et al (2012) Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol 153:804–814

    Article  Google Scholar 

  2. Kerr NM, Wang J, Barton K (2017) Minimally invasive glaucoma surgery as primary stand-alone surgery for glaucoma. Clin Exp Ophthalmol 45(4):393–400

    Article  Google Scholar 

  3. Chaudhary A, Salinas L, Guidotti J, Mermoud A, Mansouri K (2018) XEN Gel implant: a new surgical approach in glaucoma. Expert Rev Med Devices 15(1):47–59

    Article  CAS  Google Scholar 

  4. Saheb H, Ahmed IIK (2012) Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol 23:96–104

    Article  Google Scholar 

  5. Stalmans I, Fea A, Reitsamer H, Lavin CA (2015) Minimally invasive approach to sub-conjunctival outflow: 1 year results of an ab-interno gelatin stent in combination with preoperative MMC injection for the treatment of primary open angle glaucoma. Acta Ophthalmol 93:0497

    Google Scholar 

  6. Galal A, Bilgic A, Eltanamly R, Osman A, Galal A, Bilgic A, Eltanamly R, Osman A (2017) XEN Glaucoma implant with Mitomycin C 1-year follow-up: result and complications. J Ophthalmol 2017:5457246

    Article  Google Scholar 

  7. Smith M, Charles R, Abdel-Hay A, Shah B, Byles D, Lim LA, Rossiter J, Kuo CH, Chapman P, Robertson S (2019) 1-year outcomes of the Xen45 glaucoma implant. Eye (Lond) 33(5):761–766

    Article  Google Scholar 

  8. Widder RA, Dietlein TS, Dinslage S, Kühnrich P, Rennings C, Rössler G (2018) 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 256(4):765–771

    Article  Google Scholar 

  9. Mansouri K, Guidotti J, Rao HL, Ouabas A, D’Alessandro E, Roy S, Mermoud A (2018) Prospective evaluation of Standalone XEN Gel implant and combined Phacoemulsification-XEN Gel implant surgery: 1-year results. J Glaucoma 27(2):140–147

    Article  Google Scholar 

  10. Tan SZ, Walkden A, Au L (2018) One-year result of XEN45 implant for glaucoma: efficacy, safety, and postoperative management. Eye 32:324–332

    Article  Google Scholar 

  11. Hengerer FH, Kohnen T, Mueller M, Conrad-Hengerer I (2017) Ab interno gel implant for the treatment of glaucoma patients with or without prior glaucoma surgery: 1-year results. J Glaucoma 26:1130–1136

    Article  Google Scholar 

  12. Ibáñez-Muñoz A, Soto-Biforcos VS, Chacón-González R-G, Arrieta-Los Santos A, Lizuain-Abadía ME, Del Río Mayor JL (2019) One-year follow-up of the XEN implant with Mitomycin-C in pseudoexfoliative glaucoma patients. Eur J Ophthalmol 29(3):309–314

    Article  Google Scholar 

  13. Mansouri K, Gillmann K, Rao HL, Guidotti J, Mermoud A (2018) Prospective evaluation of XEN Gel implant in eyes with pseudoexfolliative glaucoma. J Glaucoma J Glaucoma 27(10):869–873

    Article  Google Scholar 

  14. Heidinger A, Schwab C, Lindner E, Riedl R, Mossböck G (2019) A retrospective study of 199 XEN45 Stent implantations from 2104 to 2016. J Glaucoma 28(1):75–79

    Article  Google Scholar 

  15. Grover DS, Flynn WJ, Bashford KP, Lewis RA, Duh YJ, Nangia RS, Niksch B (2017) Performance and safety of a new ab interno gelatin stent in refractory glaucoma at 12 months. Am J Ophthalmol 183:25–36

    Article  Google Scholar 

  16. Gillmann K, Bravetti GE, Mermoud A, Rao HL, Mansouri K (2019) XEN Gel stent in pseudoexfoliative glaucoma: 2-year results of a prospective evaluation. J Glaucoma 28(8):676–684

    Article  Google Scholar 

  17. Hohberger B, Welge-Lüßen UC, Lämmer R (2018) MIGS: therapeutic success of combined Xen Gel Stent implantation with cataract surgery. Graefes Arch Clin Exp Ophthalmol 256(3):621–625

    Article  Google Scholar 

  18. Karimi A, Lindfield D, Turnbull A, Dimitriou C, Bhatia B, Radwan M, Gouws P, Hanifudin A, Amerasinghe N, Jacob A (2019) A multi-centre interventional case series of 259 ab-interno Xen gel implants for glaucoma, with and without combined cataract surgery. Eye (Lond) 33(3):469–477

    Article  Google Scholar 

  19. De Gregorio A, Pedrotti E, Russo L, Morselli S (2018) Minimally invasive combined glaucoma and cataract surgery: clinical results of the smallest ab interno gel stent. Int Ophthalmol 38(3):1129–1134

    Article  Google Scholar 

  20. Reitsamer H, Sng C, Lenzhoferera V, M, Barton K, Stalmans I (2019) Apex Study Group. 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 257(5):983–996

    Article  CAS  Google Scholar 

  21. Pérez-Torregrosa VT, Olate-Pérez Á, Cerdà-Ibáñez M, Gargallo-Benedicto A, Osorio-Alayo V, Barreiro-Rego A, Duch-Samper A (2016) Combined phacoemulsification and XEN45 surgery from a temporal approach and 2 incisions. Arch Soc Esp Oftalmol 91(9):415–421

    Article  Google Scholar 

  22. Gabbay IE, Allen F, Morley C, Pearsall T, Bowes OM, Ruben S (2019) Efficcay and safety data for the XEN45 implant at 2 years: a retrospective analysis. Br J Ophthalmol. https://doi.org/10.1136/bjophthalmol-2019-313870. [Epub ahead of print]

  23. Fernández-García A, Zhou Y, García-Alonso M, Andrango HD, Poyales F, Garzón N (2020) Medium-term clinical outcomes following Xen45 device implantation. Int Ophthalmol 40(3):709–715

    Article  Google Scholar 

  24. Lin ZJ, Li Y, Cheng JW, Lu XH (2012) Intraoperative mitomycin C versus intraoperative 5- fluorouracil for trabeculectomy: a systematic review and meta-analysis. J Ocul Pharmacol Ther 28(2):166–173

    Article  CAS  Google Scholar 

  25. Palanca-Capistrano AM, Hall J, Cantor LB, Morgan L, Hoop J, WuDunn D (2009) Long-term outcomes of intraoperative 5-fluorouracil versus intraoperative mitomycin C in primary trabeculectomy surgery. Ophthalmology 116(2):185–190

    Article  Google Scholar 

  26. Wong TT, Khaw PT, Aung T, Foster PJ, Htoon HM, Oen FT, Gazzard G, Husain R, Devereux JG, Minassian D, Tan SB, Chew PT, Seah SK (2009) The Singapore 5-Fluorouracil trabeculectomy study: effects on intraocular pressure control and disease progression at 3 years. Ophthalmology 116(2):175–184

    Article  Google Scholar 

  27. WuDunn D, Cantor LB, Palanca-Capistrano AM, Hoop J, Alvi NP, Finley C, Lakhani V, Burnstein A, Knotts SL (2002) A prospective randomized trial comparing intraoperative 5-fluorouracil vs mitomycin C in primary trabeculectomy. Am J Ophthalmol 134:521–528

    Article  CAS  Google Scholar 

  28. Wałek E, Przeździecka-Dołyk J, Helemejko I, Misiuk-Hojło M (2020) Efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation. Int Ophthalmol 40(1):235–246

    Article  Google Scholar 

  29. Broadway DC, Bloom PA, Bunce C, Thigagrajan M, Khaw PT (2004) Needle revision of failing and failed trabeculectomy blebs with adjunctive 5-fluorouracil: survival analysis. Ophthalmology 111:665–673

    Article  Google Scholar 

  30. Midha N, Gillmann K, Chaudhary A, Mermoud A, Mansouri K (2020) Efficacy of needling revision after XEN gel stent implantation: a prospective study. J Glaucoma 29(1):11–14

    Article  Google Scholar 

  31. Arnljots TS, Kasina R, Bykov VJN, Economou MA (2018) Needling With 5-Fluorouracil (5-FU) After XEN Gel Stent Implantation: 6-Month Outcomes. J Glaucoma 27(10):893–899

    Article  Google Scholar 

  32. Abraham LM, Selva D, Casson R, Leibovitch I (2007) The clinical applications of fluorouracil in ophthalmic practice. Drugs 67:237–255

    Article  CAS  Google Scholar 

  33. Olgun A, Aktas Z, Ucgul AY (2020) XEN gel implant versus gonioscopy-assisted transluminal trabeculotomy fort the treatment of open-angle glaucoma. Int Ophthalmol https://doi.org/10.1007/s10792-019-01271-w. [Epub ahead of print]

  34. Karimi A, Hopes M, Martin KR, Lindfield D (2018) Efficacy and safety of the ab-interno Xen gel stent after failed trabeculectomy. J Glaucoma 27(10):864–868

    Article  Google Scholar 

  35. Zehavi-Dorin T, Heinecke E, Nadkarni S, Green C, Chen C, Kong YXG (2019) Bilateral consecutive Xen gel stent surgery during pregnancy for uncontrolled early-onset primary open angle glaucoma. Am J Ophthalmol Case Rep 15:100510

    Article  Google Scholar 

  36. Tailor R, Lalias T (2018) A case of refractory neovascular Glaucoma treated with a XEN 45 implant. J Glaucoma 27(10):929–930

    Article  Google Scholar 

  37. Karri B, Gupta C, Mathews D (2018) Endophthalmitis following XEN stent exposure. J Glaucoma 27(10):931–933

    Article  Google Scholar 

Download references

Funding

No financial support was received for this submission.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Esin Fatma Başer.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Informed consent

Written informed consent was obtained from all patients, and the study was conducted in accordance with the tenets of Declaration of Helsinki and its later amendments or comparable ethical standards.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Başer, E.F., Seymenoğlu, R.G. Results of fluorouracil-augmented Xen45 implantation in primary open-angle and pseudoexfoliation glaucoma. Int Ophthalmol 41, 945–955 (2021). https://doi.org/10.1007/s10792-020-01650-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10792-020-01650-8

Keywords

Navigation