Skip to main content

Advertisement

SpringerLink
Log in

Efficacy of the XEN gel stent on intraocular pressure lowering in East Asian eyes

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

Abstract

Purpose

This study aims to evaluate the efficacy and safety of XEN45 gel stent (Allergan plc, Dublin, Ireland) in East Asian patients with glaucoma.

Methods

A retrospective study of consecutive XEN45 gel stent implantation surgeries with or without concurrent cataract surgery from May 2017 to August 2018 was performed in a single institution. The clinical charts of all cases were reviewed to examine the safety and efficacy of the implant. Primary outcome measures were intraocular pressure (IOP), number of topical glaucoma medications required, additional procedures done and adverse outcomes. All patients included were required to fulfil a minimum of three follow-up visits by post-operative month 1.

Results

Sixty-three eyes were included in the study. The median duration of follow-up was 6 months [interquartile range (IQR) 2–9]. Median IOP was significantly lowered from 19 mmHg (IQR 16–24) pre-operatively to 15 mmHg (IQR 11–18) at the end-of-follow-up (p < 0.001). The median number of medications was reduced from 3 (IQR 2–4) at baseline to 0 (IQR 0–2) at the end-of-follow-up (p < 0.001). 66.7% of patients were medication-free by the end of follow-up. Post-operative bleb intervention was required for 61.9% of eyes. Adverse events included post-operative hypotony requiring intervention (4.8%) and post-operative gross hyphaema (9.6%).

Conclusion

The XEN45 gel stent when used as a sole procedure or in combination with cataract surgery in East Asian eyes is effective in the treatment of glaucoma. However, a high rate of post-operative bleb intervention appears to be required to support its efficacy.

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

Access this article

Log in via an institution

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

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Quigley HA, Broman AT (2006) The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol 90(3):262–267. https://doi.org/10.1136/bjo.2005.081224

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  2. Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M, Early Manifest Glaucoma Trial Group (2002) Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol 120(10):1268–1279

    Article  Google Scholar 

  3. Saheb H, Ahmed II (2012) Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol 23(2):96–104. https://doi.org/10.1097/ICU.0b013e32834ff1e7

    Article  PubMed  Google Scholar 

  4. Sheybani A, Dick HB, Ahmed II (2016) Early clinical results of a novel ab interno gel stent for the surgical treatment of open-angle glaucoma. J Glaucoma 25(7):e691–696. https://doi.org/10.1097/IJG.0000000000000352

    Article  PubMed  Google Scholar 

  5. Sheybani A, Reitsamer H, Ahmed II (2015) Fluid dynamics of a novel micro-fistula implant for the surgical treatment of glaucoma. Invest Ophthalmol Vis Sci 56(8):4789–4795. https://doi.org/10.1167/iovs.15-16625

    Article  CAS  PubMed  Google Scholar 

  6. Perez-Torregrosa VT, Olate-Perez A, Cerda-Ibanez 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. https://doi.org/10.1016/j.oftal.2016.02.006

    Article  CAS  PubMed  Google Scholar 

  7. Sheybani A, Lenzhofer M, Hohensinn M, Reitsamer H, Ahmed II (2015) Phacoemulsification combined with a new ab interno gel stent to treat open-angle glaucoma: pilot study. J Cataract Refract Surg 41(9):1905–1909. https://doi.org/10.1016/j.jcrs.2015.01.019

    Article  PubMed  Google Scholar 

  8. Baskaran M, Foo RC, Cheng CY, Narayanaswamy AK, Zheng YF, Wu R, Saw SM, Foster PJ, Wong TY, Aung T (2015) The prevalence and types of glaucoma in an urban Chinese population: the Singapore Chinese eye study. JAMA Ophthalmol 133(8):874–880. https://doi.org/10.1001/jamaophthalmol.2015.1110

    Article  PubMed  Google Scholar 

  9. He M, Foster PJ, Ge J, Huang W, Zheng Y, Friedman DS, Lee PS, Khaw PT (2006) Prevalence and clinical characteristics of glaucoma in adult Chinese: a population-based study in Liwan District. Guangzhou. Investigative ophthalmology & visual science 47(7):2782–2788. https://doi.org/10.1167/iovs.06-0051

    Article  Google Scholar 

  10. Liang YB, Friedman DS, Zhou Q, Yang X, Sun LP, Guo LX, Tao QS, Chang DS, Wang NL, Handan Eye Study G (2011) Prevalence of primary open angle glaucoma in a rural adult Chinese population: the Handan eye study. Invest Ophthalmol Vis Sci 52(11):8250–8257. https://doi.org/10.1167/iovs.11-7472

    Article  Google Scholar 

  11. Song W, Shan L, Cheng F, Fan P, Zhang L, Qu W, Zhang Q, Yuan H (2011) Prevalence of glaucoma in a rural northern china adult population: a population-based survey in kailu county, inner mongolia. Ophthalmology 118(10):1982–1988. https://doi.org/10.1016/j.ophtha.2011.02.050

    Article  PubMed  Google Scholar 

  12. Wang YX, Xu L, Yang H, Jonas JB (2010) Prevalence of glaucoma in North China: the Beijing eye study. Am J Ophthalmol 150(6):917–924. https://doi.org/10.1016/j.ajo.2010.06.037

    Article  PubMed  Google Scholar 

  13. Zhong H, Li J, Li C, Wei T, Cha X, Cai N, Luo T, Yu M, Yuan Y (2012) The prevalence of glaucoma in adult rural Chinese populations of the Bai nationality in Dali: the Yunnan Minority Eye Study. Invest Ophthalmol Vis Sci 53(6):3221–3225. https://doi.org/10.1167/iovs.11-9306

    Article  PubMed  Google Scholar 

  14. 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. https://doi.org/10.1007/s10792-017-0571-x

    Article  PubMed  Google Scholar 

  15. 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. https://doi.org/10.1155/2017/5457246

    Article  PubMed  PubMed Central  Google Scholar 

  16. 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. https://doi.org/10.1016/j.ajo.2017.07.023

    Article  PubMed  Google Scholar 

  17. Schlenker MB, Gulamhusein H, Conrad-Hengerer I, Somers A, Lenzhofer M, Stalmans I, Reitsamer H, Hengerer FH, Ahmed IIK (2017) Efficacy, safety, and risk factors for failure of standalone ab interno gelatin microstent implantation versus standalone trabeculectomy. Ophthalmology 124(11):1579–1588. https://doi.org/10.1016/j.ophtha.2017.05.004

    Article  PubMed  Google Scholar 

  18. Broadway DC, Chang LP (2001) Trabeculectomy, risk factors for failure and the preoperative state of the conjunctiva. J Glaucoma 10(3):237–249

    Article  CAS  Google Scholar 

  19. Husain R, Clarke JC, Seah SK, Khaw PT (2005) A review of trabeculectomy in East Asian people—the influence of race. Eye (London, England) 19(3):243–252. https://doi.org/10.1038/sj.eye.6701477

    Article  CAS  Google Scholar 

  20. Wong JS, Yip L, Tan C, Chew P (1998) Trabeculectomy survival with and without intra-operative 5-fluorouracil application in an Asian population. Aust N Z J Ophthalmol 26(4):283–288

    Article  CAS  Google Scholar 

  21. Tsai AS, Boey PY, Htoon HM, Wong TT (2015) Bleb needling outcomes for failed trabeculectomy blebs in Asian eyes: a 2-year follow up. Int J Ophthalmol 8(4):748–753. https://doi.org/10.3980/j.issn.2222-3959.2015.04.19

    Article  PubMed  PubMed Central  Google Scholar 

  22. Shaarawy T, Sherwood MB, Grehn F (2009) Guidelines on design and reporting of glaucoma surgical trials. Kugler Publications, Amsterdam

    Google Scholar 

  23. Hodapp E, Parrish RK, Anderson DR (1993) Clinical decisions in glaucoma. Mosby Inc, Maryland Height

    Google Scholar 

  24. Tan SZ, Walkden A, Au L (2018) One-year result of XEN45 implant for glaucoma: efficacy, safety, and postoperative management. Eye (Lond) 32(2):324–332. https://doi.org/10.1038/eye.2017.162

    Article  Google Scholar 

  25. 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 Ophthal 256(4):765–771

    Article  Google Scholar 

  26. Lochhead J, Casson RJ, Salmon JF (2003) Long term effect on intraocular pressure of phacotrabeculectomy compared to trabeculectomy. The British journal of ophthalmology 87(7):850–852

    Article  CAS  Google Scholar 

  27. Baudouin C, Pisella PJ, Fillacier K, Goldschild M, Becquet F, De Saint JM, Bechetoille A (1999) Ocular surface inflammatory changes induced by topical antiglaucoma drugs: human and animal studies. Ophthalmology 106(3):556–563. https://doi.org/10.1016/S0161-6420(99)90116-1

    Article  CAS  PubMed  Google Scholar 

  28. Broadway DC, Grierson I, O'Brien C, Hitchings RA (1994) Adverse effects of topical antiglaucoma medication. II. The outcome of filtration surgery. Arch Ophthalmol 112(11):1446–1454

    Article  CAS  Google Scholar 

  29. 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. https://doi.org/10.1097/IJG.0000000000001052

    Article  PubMed  Google Scholar 

  30. Broadway DC, Bloom PA, Bunce C, Thiagarajan M, Khaw PT (2004) Needle revision of failing and failed trabeculectomy blebs with adjunctive 5-fluorouracil: survival analysis. Ophthalmology 111(4):665–673. https://doi.org/10.1016/j.ophtha.2003.07.009

    Article  PubMed  Google Scholar 

  31. Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC, Tube Versus Trabeculectomy Study Group (2012) Postoperative complications in the tube versus trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol 153(5):804–814 e801. https://doi.org/10.1016/j.ajo.2011.10.024

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Funding

The authors declare this study received no funding.

Author information

Author notes

  1. Jeremy Hu and Bryan Ang have contributed equally to this work.

Authors and Affiliations

  1. Department of Ophthalmology, National Healthcare Group Eye Institute, Tan Tock Seng Hospital, Singapore, Singapore

    Jeremy Y. Hu, Bryan C. H. Ang & Leonard W. Yip

  2. Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore

    Leonard W. Yip

Authors
  1. Jeremy Y. Hu
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Bryan C. H. Ang
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Leonard W. Yip
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Leonard W. Yip.

Ethics declarations

Conflict of interest

Dr. Leonard Yip and Dr. Bryan Ang are Consultants to Allergan. Dr. Jeremy Hu declare no conflict of interest.

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

Hu, J.Y., Ang, B.C.H. & Yip, L.W. Efficacy of the XEN gel stent on intraocular pressure lowering in East Asian eyes. Int Ophthalmol 40, 1191–1199 (2020). https://doi.org/10.1007/s10792-020-01284-w

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10792-020-01284-w

Keywords

Search

Navigation