Skip to main content

Advertisement

SpringerLink
Log in

XEN implant device versus trabeculectomy, either alone or in combination with phacoemulsification, in open-angle glaucoma patients

  • Glaucoma
  • Published:
Graefe's Archive for Clinical and Experimental Ophthalmology Aims and scope Submit manuscript

Abstract

Purpose

To compare the efficacy and safety of the XEN45 implant with that of trabeculectomy (TRAB), either alone or in combination with phacoemulsification (PHACO), in patients with open-angle glaucoma (OAG).

Methods

Retrospective, single-center and comparative study conducted on OAG patients. Patients were divided into four groups: group 1 (XEN alone); group 2 (XEN+PHACO); group 3 (TRAB alone); group 4 (TRAB+PHACO). For statistical purposes, groups 1 and 2 were combined (XEN implant), while groups 3 and 4 were also combined (TRAB surgery). The main outcome measure was intraocular pressure (IOP).

Results

Ninety-one patients (121 eyes; 65 XEN and 56 TRAB) were included. IOP reduction was − 6.7 (− 10.4 to − 3.0) mmHg, p = 0.0013; − 3.5 (− 5.0 to − 2.0) mmHg, p < 0.0001; − 8.1 (− 10.4 to − 5.9) mmHg, p < 0.0001l; and − 7.3 (− 9.3 to − 5.3) mmHg, p < 0.0001 in the XEN alone, XEN+PHACO, TRAB alone, and TRAB+PHACO, respectively. At month 12, an IOP ≥ 6 and ≤ 16 mm without treatment was achieved by 44 (67.7%) and 43 (76.8%), p = 0.2687 in the XEN implant and the TRAB surgery groups, respectively. The mean number of antiglaucoma medications was significantly reduced in all the study groups (p < 0.0001 each). Needling occurred in 20.0% (13/65) of eyes in the XEN implant group, while hyphema occurred in 30.4% (17/56) of eyes in the TRAB group.

Conclusions

XEN implant, either alone or in combination with phacoemulsification, significantly reduces both IOP and the number of antiglaucoma medications to a similar rate than trabeculectomy, but with a better safety profile.

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. 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  PubMed  Google Scholar 

  2. Dreer LE, Girkin C, Mansberger SL (2012) Determinants of medication adherence to topical glaucoma therapy. J Glaucoma 21(4):234–240. https://doi.org/10.1097/IJG.0b013e31821dac86

    Article  PubMed  PubMed Central  Google Scholar 

  3. Lemij HG, Hoevenaars JG, van der Windt C, Baudouin C (2015) Patient satisfaction with glaucoma therapy: reality or myth? Clin Ophthalmol 9:785–793. https://doi.org/10.2147/OPTH.S78918

    Article  PubMed  PubMed Central  Google Scholar 

  4. Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee PP (2015) The most common barriers to glaucoma medication adherence: a cross-sectional survey. Ophthalmology 122(7):1308–1316. https://doi.org/10.1016/j.ophtha.2015.03.026

    Article  PubMed  Google Scholar 

  5. Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA, Mills RP, CIGTS Study Group (2001) Interim clinical outcomes in the collaborative initial glaucoma treatment study comparing initial treatment randomized to medications or surgery. Ophthalmology 108(11):1943–1953

    Article  CAS  PubMed  Google Scholar 

  6. Musch DC, Gillespie BW, Lichter PR, Niziol LM, Janz NK, CIGTS Study Investigators (2009) Visual field progression in the collaborative initial glaucoma treatment study the impact of treatment and other baseline factors. Ophthalmology 116(2):200–207. https://doi.org/10.1016/j.ophtha.2008.08.051

    Article  PubMed  Google Scholar 

  7. Burr J, Azuara-Blanco A, Avenell A, Tuulonen A (2012) Medical versus surgical interventions for open angle glaucoma. Cochrane Database Syst Rev 9:CD004399. https://doi.org/10.1002/14651858.CD004399.pub3

    Article  Google Scholar 

  8. Landers J, Martin K, Sarkies N, Bourne R, Watson P (2012) A twenty-year follow-up study of trabeculectomy: risk factors and outcomes. Ophthalmology 119(4):694–702. https://doi.org/10.1016/j.ophtha.2011.09.043

    Article  PubMed  Google Scholar 

  9. Tseng VL, Coleman AL, Chang MY, Caprioli J (2017) Aqueous shunts for glaucoma. Cochrane Database Syst Rev 7:CD004918. https://doi.org/10.1002/14651858.CD004918.pub3

    Article  PubMed  Google Scholar 

  10. 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.e1. https://doi.org/10.1016/j.ajo.2011.10.024

    Article  PubMed  PubMed Central  Google Scholar 

  11. Minckler D, Mosaed S, Dustin L, Ms BF, Trabectome Study Group (2008) Trabectome (trabeculectomy-internal approach): additional experience and extended follow-up. Trans Am Ophthalmol Soc 106:149–159 discussion 159-60

    PubMed  PubMed Central  Google Scholar 

  12. Ting JL, Damji KF, Stiles MC, Trabectome Study Group (2012) Ab interno trabeculectomy: outcomes in exfoliation versus primary open-angle glaucoma. J Cataract Refract Surg 38(2):315–323. https://doi.org/10.1016/j.jcrs.2011.08.043

    Article  PubMed  Google Scholar 

  13. Bussel II, Kaplowitz K, Schuman JS, Loewen NA, Trabectome Study Group (2015) Outcomes of ab interno trabeculectomy with the trabectome by degree of angle opening. Br J Ophthalmol 99(7):914–919. https://doi.org/10.1136/bjophthalmol-2014-305577

    Article  CAS  PubMed  Google Scholar 

  14. Ansari E (2017) An update on implants for minimally invasive glaucoma surgery (MIGS). Ophthalmol Ther 6(2):233–241. https://doi.org/10.1007/s40123-017-0098-2

    Article  PubMed  PubMed Central  Google Scholar 

  15. 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. https://doi.org/10.1080/17434440.2018.1419060

    Article  CAS  PubMed  Google Scholar 

  16. Bar-David L, Blumenthal EZ (2018). Evolution of glaucoma surgery in the last 25 years. Rambam Maimonides Med J; 9(3). doi: https://doi.org/10.5041/RMMJ.10345

  17. Sng CCA, Barton K (2018) Minimally invasive glaucoma surgery - coming of age. Br J Ophthalmol 102(10):1315–1316. https://doi.org/10.1136/bjophthalmol-2018-313170

    Article  PubMed  Google Scholar 

  18. Lavia C, Dallorto L, Maule M, Ceccarelli M, Fea AM (2017) Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: a systematic review and meta-analysis. PLoS One 12(8):e0183142. https://doi.org/10.1371/journal.pone.0183142

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  19. De Gregorio A, Pedrotti E, Stevan G, Bertoncello A, Morselli S (2018) XEN glaucoma treatment system in the management of refractory glaucomas: a short review on trial data and potential role in clinical practice. Clin Ophthalmol 12:773–782. https://doi.org/10.2147/OPTH.S146919

    Article  PubMed  PubMed Central  Google Scholar 

  20. 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 

  21. 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 Erratum in: Ophthalmology. 2018 Mar;125(3):463

    Article  PubMed  Google Scholar 

  22. 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. https://doi.org/10.1016/j.oftal.2016.02.006

    Article  PubMed  Google Scholar 

  23. Ozal SA, Kaplaner O, Basar BB, Guclu H, Ozal E (2017) An innovation in glaucoma surgery: XEN45 gel stent implantation. Arq Bras Oftalmol 80(6):382–385. https://doi.org/10.5935/0004-2749.20170093

    Article  PubMed  Google Scholar 

  24. 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 

  25. 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 

  26. 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. https://doi.org/10.1097/IJG.0000000000000858

    Article  PubMed  Google Scholar 

  27. 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. https://doi.org/10.1007/s00417-018-3899-7

    Article  PubMed  Google Scholar 

  28. 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. https://doi.org/10.1007/s00417-017-3895-3

    Article  PubMed  Google Scholar 

  29. Ibáñez-Muñoz A, Soto-Biforcos VS, Chacón-González M, Rúa-Galisteo O, Arrieta-Los Santos A, Lizuain-Abadía ME, Del Río Mayor JL (2018). One-year follow-up of the XEN® implant with mitomycin-C in pseudoexfoliative glaucoma patients. Eur J Ophthalmol: 1120672118795063. doi: https://doi.org/10.1177/1120672118795063

  30. Bloom P, Au L (2018). “Minimally invasive glaucoma surgery (MIGS) is a poor substitute for trabeculectomy”—the great debate. Ophthalmol Ther doi: https://doi.org/10.1007/s40123-018-0135-9

  31. Jiang N, Zhao GQ, Lin J, Hu LT, Che CY, Wang Q, Xu Q, Li C, Zhang J (2018) Meta-analysis of the efficacy and safety of combined surgery in the management of eyes with coexisting cataract and open angle glaucoma. Int J Ophthalmol 11(2):279–286. https://doi.org/10.18240/ijo.2018.02.17

    Article  PubMed  PubMed Central  Google Scholar 

  32. Sałaga-Pylak M, Kowal M, Zarnowski T (2013) Deterioration of filtering bleb morphology and function after phacoemulsification. BMC Ophthalmol 13:17. https://doi.org/10.1186/1471-2415-13-17

    Article  PubMed  PubMed Central  Google Scholar 

  33. Rotchford AP, Vernon SA (2007) Phaco-microtrabeculectomy: technique and intraocular pressure control in comparison with microtrabeculectomy. Clin Exp Ophthalmol 35(9):812–817. https://doi.org/10.1111/j.1442-9071.2007.01604.x

    Article  PubMed  Google Scholar 

  34. Chihara E, Hayashi K (2011) Different modes of intraocular pressure reduction after three different nonfiltering surgeries and trabeculectomy. Jpn J Ophthalmol 55(2):107–114. https://doi.org/10.1007/s10384-010-0923-9

    Article  PubMed  Google Scholar 

  35. Edmunds B, Thompson JR, Salmon JF, Wormald RP (2002) The national survey of trabeculectomy. III. Early and late complications. Eye (Lond) 16(3):297–303

    Article  CAS  Google Scholar 

  36. Arimura S, Takihara Y, Miyake S, Iwasaki K, Gozawa M, Matsumura T, Tomomatsu T, Takamura Y, Inatani M (2016) Randomized clinical trial for early postoperative complications of ex-PRESS implantation versus trabeculectomy: complications postoperatively of ex-PRESS versus trabeculectomy study (CPETS). Sci Rep 6:26080. https://doi.org/10.1038/srep26080

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  37. Hirooka K, Nitta E, Ukegawa K, Tsujikawa A (2017) Vision-related quality of life following glaucoma filtration surgery. BMC Ophthalmol 17(1):66. https://doi.org/10.1186/s12886-017-0466-7

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgments

The authors wish to acknowledge Allergan Laboratories for their support with the medical writing. Editorial assistance in the preparation of this manuscript was provided by Antonio Martinez MD (Ciencia y Deporte S.L.).

Funding

Support for this assistance was funded by Allergan S.A.

Author information

Authors and Affiliations

  1. Ophthalmology Department, Hospital General Universitario de Alicante, Alicante, Pintor Baeza, 11, 03010, Alicante, Spain

    María Teresa Marcos Parra, Javier Alejandro Salinas López, Noelia Soledad López Grau, Ana María Ceausescu & Juan José Pérez Santonja

Authors
  1. María Teresa Marcos Parra
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Javier Alejandro Salinas López
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Noelia Soledad López Grau
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Ana María Ceausescu
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Juan José Pérez Santonja
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to María Teresa Marcos Parra.

Ethics declarations

Conflict of interest

Dr. Marcos has received a grant from Allergan during the conduct of the study.

None of the co-authors have any conflict of interest to declare.

Research involving human participants and/or animalsEthical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

The local ethics committee waived the need for written informed consent of the participants.

Disclaimer

It should be noted that Allergan S.A. was not involved in the preparation of the manuscript nor did the company influence in any way the scientific conclusions reached.

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

Marcos Parra, M.T., Salinas López, J.A., López Grau, N.S. et al. XEN implant device versus trabeculectomy, either alone or in combination with phacoemulsification, in open-angle glaucoma patients. Graefes Arch Clin Exp Ophthalmol 257, 1741–1750 (2019). https://doi.org/10.1007/s00417-019-04341-y

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00417-019-04341-y

Keywords

Search

Navigation