PRESERFLO™ MicroShunt versus trabeculectomy: first results on efficacy and safety

Abstract

Purpose To report efficacy and safety outcomes of the PRESERFLO™ MicroShunt compared with trabeculectomy, the current gold‐standard treatment for advanced glaucoma, in the early and intermediate postoperative period. Methods Institutional prospective interventional cohort study of primary open‐angle glaucoma (POAG) patients scheduled for the PRESERFLO™ MicroShunt. The comparison group were POAG patients who had had received trabeculectomy and were matched for age, known duration of disease, number and classes of intraocular pressure (IOP)‐lowering medications to ensure a similar conjunctival condition. The study is part of the Dresden Glaucoma and Treatment Study (DGTS), was not randomized, but used a uniform study design, with the same inclusion and exclusion criteria as well as standardized definitions of success and failure. Main outcome measures: mean diurnal IOP (mdIOP, mean of 6 measurements), diurnal peak IOP, diurnal IOP fluctuations, glaucoma medical therapy, success rates, visual acuity, visual fields, surgical complications and interventions, and severe adverse events. Results Fifty‐two eyes of 52 patients, 26 in each group, were analysed. At 6 months, median [Q25, Q75] mdIOP was 10.8 [9.5–12.2] mmHg in the microshunt and 10.3 [7.6–11.8] mmHg in the trabeculectomy group. Reduction in mdIOP (p = 0.458), peak diurnal IOP (p = 0.539), and median diurnal fluctuation (p = 0.693) was not statistically significantly different between groups. The rate of interventions was statistically significantly higher in the trabeculectomy compared with the microshunt group (p = 0.004). None of the patients experienced severe adverse events. Conclusion Both procedures are equally effective and safe in lowering mdIOP in patients with POAG. Because the microshunt is less invasive with less follow‐up and interventions needed postoperatively, it might be recommended earlier in the treatment of glaucoma.

Corneal Endothelial Cell Loss in Patients After Minimally Invasive Glaucoma Surgery: Current Perspectives

“…A study reported no changes in the ECD and %HEX at 6 months after PRESEFFLO microshunt implantation; however, there was a significant change in the CV (p = 0.003). 68 A large multicenter study reported a CECL of 5.2% at 1 year after PRESERFLO Microshunt implantation. In one case, the CECL value was higher (9.4%), which was attributed to the close proximity of the microshunt to the cornea.…”

PreserFlo® MicroShunt: An Overview of This Minimally Invasive Device for Open-Angle Glaucoma

“…In this panorama, the PreserFlo MicroShunt efficacy and safety have recently been compared with trabeculectomy as a primary treatment for POAG. Pillunat’s research yielded the initial results in glaucomatous patients who had undergone PreserFlo implantation alone vs. MMC-augmented trabeculectomy [ 43 ]. A total of 52 eyes were studied, with 26 in each group and comparable pre-operative IOPs among the two groups.…”

“…The trabeculectomy group had a statistically significant greater rate of post-operative interventions than the MicroShunt group, which might balance the higher costs of PreserFlo at time of surgery. None of the patients had any serious side effects [ 43 ].…”

Corneal Endothelial Cell Loss in Glaucoma and Glaucoma Surgery and the Utility of Management with Descemet Membrane Endothelial Keratoplasty (DMEK)

“…In recent years, the Preserflo (formerly InnFocus) (Santen Co., Japan), which creates a bleb by the insertion of an 8.5 mm polymeric in anterior chamber via a scleral pocket, has come to the market. Results showed no significant difference at 6 months between endothelial cell loss in 26 eyes with Preserflo (gain of 2.7%) compared to 26 after trabeculectomy (loss of 3.2%) [ 139 ]. Both procedures significantly changed the coefficient of variation but had no significant changes on percentage of hexagonal cells.…”