2025 - 4 Issue

Original article

Two-Year Results of Preserflo Microshunt Use in Open-Angle Glaucoma Surgery

Full Text links

Summary

Aim: To evaluate the safety and efficacy outcomes of PRESERFLO™ MicroShunt implantation in patients with primary open-angle glaucoma.

Material and Methods: Retrospective data analysis of 19 eyes of 12 patients, comprising 5 females and 7 males. The patients underwent surgery between August 2020 and February 2022. The follow-up period was 24 months after surgery. During the follow-up period, intraocular pressure (IOP), the need to apply topical antiglaucoma medication and its spectrum, visual field status, optic nerve target findings and postoperative complications were recorded. The indication for PRESERFLO™ MicroShunt implantation was primary open angle glaucoma (POAG), poorly controlled with maximum tolerated medical therapy.

Results: Average IOP was reduced from 19.05 ±5.58 mmHg preoperatively to 11.47 ±2.48 mmHg at 3 months postoperatively, 12.26 ±2.48 mmHg at 6 months postoperatively, 14.0 ±2.43 mmHg at 12 months postoperatively, 11.78 ±2.37 mmHg at 18 months postoperatively, and 12.73 ±2.51 mmHg at 24 months postoperatively (p < 0.001).
No antiglaucoma medication was required in 19 eyes 3 months after surgery, in 19 eyes 6 months after surgery, 19 eyes 12 months after surgery, 16 eyes 18 months after surgery and 15 eyes 24 months after surgery. One eye (5.26%) required monotherapy 18 months after surgery, and 2 eyes (10.52%) 24 months after surgery. Dual combination therapy was required 18 months after surgery in 2 eyes (10.52%) and 24 months after surgery in 2 eyes (10.52%). In the early postoperative period we found a loose conjunctival suture in 3 eyes, which was followed by resuturing in 1 eye. In the late postoperative period we found an obturated implant in 1 eye, which required implant replacement.

Conclusion: Our initial results suggest that the PRESERFLO™ MicroShunt glaucoma implant is an effective surgical technique with minimal postoperative complications, resulting in a statistically significant reduction in average IOP and discontinuation or reduction of topical antiglaucoma medication for 2 years after surgery.

References

  1. Batlle JF, Corona A, Albuquerque R. Long-term Results of the PRE- SERFLO MicroShunt in Patients With Primary Open-angle Glaucoma From a Single-center Nonrandomized Study. J Glaucoma. 2021 Mar 1;30(3):281-286. doi: 10.1097/IJG.0000000000001734
  2. Dervos T, Gugleta K, Scholl HPN, Gatzioufas Z, Enz TJ. Single versus Double PreserFlo MicroShunt Implantation in Glaucoma Patients: A Retrospective Cohort Study. Ophthalmic Res. 2023;66(1):1362- 1375. doi: 10.1159/000535276
  3. Gambini G, Carlà MM, Giannuzzi F, et al. PreserFlo ® MicroShunt: An Overview of This Minimally Invasive Device for Open-Angle Glaucoma. Vision (Basel). 2022 Feb 9;6(1):12. doi: 10.3390/vision6010012
  4. Ibarz-Barberá M, Morales-Fernández L, Corroto-Cuadrado A, et al. Corneal Endothelial Cell Loss After PRESERFLO™ MicroShunt Implantation in the Anterior Chamber: Anterior Segment OCT Tube Location as a Risk Factor. Ophthalmol Ther. 2022 Feb;11(1):293-
  5. Beckers HJM, Aptel F, Webers CAB, et al. Safety and Effectiveness of the PRESERFLO® MicroShunt in Primary Open-Angle Glaucoma: Results from a 2 – Year Multicenter Study. Ophthalmol Glaucoma. 2022 Mar-Apr;5(2):195-209. doi: 10.1016/j.ogla.2021.07.008
  6. Qin Q, Zhang C, Yu N, et al. Development and material characteristics of glaucoma surgical implants. Adv Ophthalmol Pract Res. 2023 Sep 23;3(4):171-179. doi: 10.1016/j.aopr.2023.09.001
  7. Saeed E, Gołaszewska K, Dmuchowska DA, Zalewska R, Konopińska J. The PreserFlo MicroShunt in the Context of Minimally Invasive Glaucoma Surgery: A Narrative Review. Int J Environ Res Public Health. 2023 Feb 7;20(4):2904. doi: 10.3390/ijerph20042904
  8. Scheres LMJ, Kujovic-Aleksov S, Ramdas WD, et al. XEN ® Gel Stent compared to PRESERFLO™ MicroShunt implantation for primary open-angle glaucoma: two-year results. Acta Ophthalmol. 2021 May;99(3): e433-e440. doi: 10.1111/aos.14602
  9. Bhayani R, Martínez de la Casa JM, et al. Short-term safety and efficacy of Preserflo™ Microshunt in glaucoma patients: a multicentre retrospective cohort study. Eye (Lond). 2023 Mar;37(4):644-649. doi: 10.1038/s41433-022-01995-7
  10. Bunod R, Robin M, Buffault J, Keilani C, Labbé A, Baudouin C. PreserFlo MicroShunt® exposure: a case series. BMC Ophthalmol. 2021 Jul 10;21(1):273. doi: 10.1186/s12886-021-02032-z
  11. Habbe KJ, Kohlhaas M, Fili S. PreserFlo™ MicroShunt Versus Ab Externo Canaloplasty in Patients With Moderate to Advanced Open- -Angle Glaucoma: 12 – Month Follow-Up of a Single-Center Retrospective Study. Cureus. 2023 Feb 19;15(2): e35185. doi: 10.7759/ cureus.35185
  12. Storp JJ, Vietmeier FE, Merté RL, et al. Long-Term Outcomes of the PRESERFLO MicroShunt Implant in a Heterogeneous Glaucoma Cohort. J Clin Med. 2023 Jul 4;12(13):4474. doi: 10.3390/jcm12134474
  13. Tanner A, Haddad F, Fajardo-Sanchez J, et al. One-year surgical outcomes of the PreserFlo MicroShunt in glaucoma: a multicentre analysis. Br J Ophthalmol. 2023 Aug;107(8):1104-1111. doi: 10.1136/bjophthalmol-2021-320631
  14. Batlle JF, Fantes F, Riss I, et al. Three-Year Follow-up of a Novel Aqueous Humor MicroShunt. J Glaucoma. 2016 Feb;25(2): e58-65. doi: 10.1097/IJG.0000000000000368. PMID: 26766400
  15. Ibarz Barberá M, Martínez-Galdón F, Caballero-Magro E, Rodríguez-Piñero M, Tañá-Rivero P. Efficacy and Safety of the Preserflo Microshunt With Mitomycin C for the Treatment of Open Angle Glaucoma. J Glaucoma. 2022 Jul 1;31(7):557-566. doi: 10.1097/ IJG.0000000000002052
  16. Ahmed IIK, Sadruddin O, Panarelli JF. Subconjunctival filtration in evolution: current evidence on MicroShunt implantation for treating patients with glaucoma. Eye Vis (Lond). 2023 Mar 2;10(1):10. doi: 10.1186/s40662-022-00322-1
  17. Fili S, Kontopoulou K, Vastardis I, Perdikakis G, Bechrakis N, Kohlhaas M. PreserFlo™ MicroShunt Combined with Phacoemulsification versus PreserFlo™ MicroShunt as a Standalone Procedure in Patients with Medically Resistant Open-Angle Glaucoma. J Curr Ophthalmol. 2022 Jul 26;34(2):180-186. doi: 10.4103/joco. joco_298_21
  18. Fea AM, Ghilardi A, Bovone D, Reibaldi M, Rossi A, Craven ER. A New and Easier Approach to Preserflo MicroShunt Implantation. Clin Ophthalmol. 2022 Apr 27; 16:1281-1288. doi: 10.2147/OPTH. S307835
  19. Gubser PA, Pfeiffer V, Hug S, et al. PRESERFLO MicroShunt implantation versus trabeculectomy for primary open-angle glaucoma: a two-year follow-up study. Eye Vis (Lond). 2023 Dec 21;10(1):50. doi: 10.1186/s40662-023-00369-8
  20. Baker ND, Barnebey HS, Moster MR, et al. Ab-Externo Micro- Shunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study. Ophthalmology. 2021 Dec;128(12):1710-1721. doi: 10.1016/j. ophtha.2021.05.023
  21. doi: 10.1007/s40123-021-00428-0