Ahead of print

Original article

Long-term Evaluation of the Efficacy and Safety of the EX-PRESS® Glaucoma Drainage Device in the Treatment of Primary Open-Angle Glaucoma: A Five-Year Retrospective Study

Veronika Fialová ORCID
Martin Váša – Pavel Rozsíval ORCID – Jan Studnička ORCID – Marek Zanker

Full Text links

Keywords: primary open-angle glaucoma, filtration surgery, EX-PRESS implant, intraocular pressure, antiglaucoma medication

Summary

Aim: To evaluate the long-term efficacy and safety of the EX-PRESS glaucoma drainage device implantation in patients with primary open-angle glaucoma over a five-year follow-up period.

Materials and Methods: The retrospective analysis included 77 eyes of 58 patients (28 women, 30 men) who underwent EX-PRESS glaucoma drainage device implantation between 2011 and 2020. The follow-up period was 60 months for all eyes. The evaluated parameters included intraocular pressure (IOP), the need for and type of antiglaucoma medication, best-corrected visual acuity (BCVA), optic nerve head findings, mean deviation (MD) of visual field testing, and the incidence of postoperative complications. The indication for surgery was primary open-angle glaucoma which was insufficiently controlled despite maximally tolerated medical therapy.

Results: Mean intraocular pressure (IOP) was reduced from 23.55 ±9.54 mmHg preoperatively to 12.61 ±6.83 mmHg at 3 months, 13.04 ±3.95 mmHg at 12 months, 13.39 ±3.33 mmHg at 24 months, 13.48 ±3.75 mmHg at 36 months, 13.53 ±3.23 mmHg at 48 months, and 13.52 ±2.96 mmHg at 60 months. After surgery, a marked reduction in antiglaucoma medication was observed. A total of 84.4% of eyes required no medication at 3 months, decreasing to 72.7% at 12 months, 49.4% at 24 months, 42.9% at 36 months, 42.9% at 48 months, and 42.9% at 60 months. The mean number of antiglaucoma medications decreased from 3.19 to 1.09, representing a 66% reduction. No intraoperative complications were observed. Early postoperative complications included hypotony in 6 eyes, choroidal detachment in 14 eyes, subconjunctival hemorrhage in 5 eyes, iris incarceration in 2 eyes, and conjunctival suture loosening in 6 eyes. Late postoperative complications included filtration failure in 1 eye, endophthalmitis in 1 eye, and implant obstruction in 2 eyes. In one case, PRESERFLO™ MicroShunt implantation was performed 5 years after EX-PRESS implantation.

Conclusion: EX-PRESS glaucoma drainage device implantation is an effective surgical method for the treatment of glaucoma, which provides long-term stability. It enables a significant reduction of intraocular pressure with a concurrent decrease in the need for antiglaucoma medication, and demonstrates an acceptable safety profile over a five-year follow-up period.

References

  1. Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA. 2014;311(18):1901-1911.
  2. Jayaram H. Intraocular pressure reduction in glaucoma: does every mmHg count? Taiwan J Ophthalmol. 2020;10(4):255-258.
  3. Quaranta L, Novella A, Tettamanti M, Pasina L, Weinreb RN, Nobili A. Adherence and persistence to medical therapy in glaucoma: an overview. Ophthalmol Ther. 2023;12(5):2227-2240.
  4. Gedde SJ. Results from the tube versus trabeculectomy study. Middle East Afr J Ophthalmol. 2009;16(3):107-111.
  5. Wang W, Zhou M, Huang W, Zhang X. Ex-PRESS implantation versus trabeculectomy in uncontrolled glaucoma: a meta-analysis. PLoS One. 2013;8(5):e63591.
  6. Pillunat LE, Erb C, Jünemann AG, Kimmich F. Micro-invasive glaucoma surgery (MIGS): a review of surgical procedures using stents. Clin Ophthalmol. 2017;11:1583-1600.
  7. Dahan E, Carmichael TR. Implantation of a miniature glaucoma device under a scleral flap. J Glaucoma. 2005;14(2):98-102.
  8. Zhang X, Wang B, Liu R, et al. The effectiveness of AGV, Ex-PRESS, or trabeculectomy in the treatment of primary and secondary glaucoma: a systematic review and network meta-analysis. Ann Palliat Med. 2022;11(1):321-331.
  9. Dahan E, Ben Simon GJ, Lafuma A. Comparison of trabeculectomy and EX-PRESS implantation in fellow eyes of the same patient: a prospective randomized study. Eye (Lond). 2012;26(5):703-710.
  10. Kanner EM, Netland PA, Sarkisian SR Jr, Du H. EX-PRESS miniature glaucoma device implanted under a scleral flap alone or combined with phacoemulsification cataract surgery. J Glaucoma. 2009;18(6):488-491.
  11. de Jong L, Lafuma A, Aguadé AS, Berdeaux G. Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma. Clin Ophthalmol. 2011;5:527-533.
  12. Mariotti C, Dahan E, Nicolai M, Levitz L, Bouée S. Long-term outcomes and risk factors for failure with the EX-PRESS glaucoma drainage device. Eye (Lond). 2014;28(1):1-8.
  13. Wilkins M, Indar A, Wormald R. Intra-operative mitomycin C for glaucoma surgery. Cochrane Database Syst Rev. 2005;(4):CD002897.
  14. Netland PA, Sarkisian SR Jr, Moster MR, et al. Randomized prospective comparative trial of EX-PRESS glaucoma filtration device versus trabeculectomy. Am J Ophthalmol. 2014;157(2):433-440.
  15. Puerto B, López-Caballero C, Sánchez-Sánchez C, Oblanca N, Blázquez V, Contreras I. Clinical outcomes after EX-PRESS glaucoma shunt versus non-penetrating deep sclerectomy: two-year follow-up. Int Ophthalmol. 2018;38(6):2575-2584.
  16. Graffi S, Tiosano B, Naftali M, et al. Short-term anterior chamber inflammation in phacoemulsification with and without EX-PRESS glaucoma implant. Eur J Ophthalmol. 2020;30(3):533-537.
  17. Konopińska J, Byszewska A, Saeed E, Mariak Z, Rękas M. Phacotrabeculectomy versus phaco with implantation of the EX-PRESS device: surgical and refractive outcomes – a randomized controlled trial. J Clin Med. 2021;10(3):424.
  18. Aihara M, Kuwayama Y, Miyata K, et al. Twelve-month efficacy and safety of glaucoma filtration device in patients with normal-tension glaucoma. Jpn J Ophthalmol. 2019;63(5):402-409.
  19. Abd El Rehim DAF, El-Hessy AAA, El-Kholy SEE, Nematalla EH, El-Saeed EM. Effect of EX-PRESS glaucoma filtration device on corneal endothelium in primary open-angle glaucoma. J Egypt Ophthalmol Soc. 2019;112:9-13.
  20. Ren X, Wang J, Li X, Wu L. Long-term changes in corneal endothelial cell density after EX-PRESS implantation: a contralateral eye study. J Clin Med. 2022;11(19):5555.
  21. Arimura S, Miyake S, Iwasaki K, et al. Randomised clinical trial for postoperative complications after EX-PRESS implantation versus trabeculectomy with 2-year follow-up. Sci Rep. 2018;8:16168.
  22. Tojo N, Numata A, Hayashi A. Factors influencing the reduction in corneal endothelial cells after EX-PRESS surgery. Int Ophthalmol. 2020;40(5):1201-1208.
  23. Tojo N, Hayashi A, Miyakoshi A. Corneal decompensation following filtering surgery with the EX-PRESS mini glaucoma shunt device. Clin Ophthalmol. 2015;9:499-502.
  24. Yamazaki H, Tojo N, Otsuka M, Tomoko UC, Hayashi A. Comparison of corneal endothelial cell density reduction between primary open-angle glaucoma and pseudoexfoliation glaucoma patients after EX-PRESS surgery. Int Ophthalmol. 2024;44(1):333.
  25. Cillino S, Casuccio A, Di Pace F, Cagini C, Ferraro LL, Cillino G. Biodegradable collagen matrix implant versus mitomycin C in trabeculectomy: five-year follow-up. BMC Ophthalmol. 2016;16:24.
  26. Fialová V, Váša M. Use of EX-PRESS implant in glaucoma surgery: retrospective study. Cesk Slov Oftalmol. 2018;74(1):9-14.