Preserflo TM MicroShunt implantation combined with Ologen TM in primary and secondary glaucoma patients in a clinical setting

Abstract

Purpose: This study aims to assess the effectiveness and safety of combining the Preserflo™ MicroShunt implant (MicroShunt) with a simultaneous Ologen™ implant in patients with glaucoma.

Methods: We conducted a retrospective study on consecutive patients with medically uncontrolled glaucoma who underwent MicroShunt + Ologen implantation as a standalone procedure or in combination with phacoemulsification (combined procedure). Success was defined as achieving an intraocular pressure (IOP) of 6-15 mmHg at 18 months post surgery, with a preoperative IOP reduction of at least 20%, and without (complete success) or with (qualified success) the need for antiglaucoma medications. The primary endpoint was the success rate.

Results: Forty-eight eyes from 47 patients were included, with 28 eyes (58.3%) undergoing the standalone procedure and 20 eyes (41.7%) undergoing the combined procedure. Overall, there was a significant reduction in preoperative IOP from 19.7 ± 5.8 mmHg to 11.4 ± 2.6 mmHg at 18 months ( P < 0.0001). In the standalone procedure group, preoperative IOP decreased from 21.5 ± 5.2 mmHg to 11.7 ± 2.5 mmHg ( P < 0.0001), and in the combined procedure group, preoperative IOP decreased from 17.1 ± 5.8 mmHg to 10.9 ± 2.7 mmHg ( P = 0.0002), with no significant difference between the two groups regarding final IOP. The mean number of antiglaucoma medications significantly decreased from 3.2 ± 1.1 to 0.3 ± 0.7 in the overall study population ( P < 0.0001). At 18 months, 40 eyes (83.3%) were classified as successful. Regarding safety, out of the total number of eyes, two (4.2%) experienced choroidal detachment without visual impairment, two (4.2%) had transient hyphema, one (2.1%) showed reactivation of a corneal herpetic ulcer, one (2.1%) had diplopia, and one (2.1%) exhibited a shallow anterior chamber during the first week.

Conclusion: The combination of Ologen™ and Preserflo™ MicroShunt, either alone or in conjunction with phacoemulsification, demonstrated a favorable profile in terms of IOP reduction and safety.

Figure 1

Kaplan–Meier survival analysis. The mean hazard ratio was 4.56 (95% CI: 1.06–19.59, P = 0.0414)

Figure 2

Mean intraocular pressure (IOP) over the course of follow-up. The vertical bars represent the 95% confidence interval. (a) Overall study population. *P < 0.0001 as compared to preoperative value (repeated measures ANOVA and the Greenhouse-Geisser correction). (b) Comparison between eyes that underwent MicroShunt-solo and those that underwent MicroShunt + phacoemulsification (MicroShunt + Phaco) surgery. The preoperative mean IOP was significantly lower in the MicroShunt + Phaco group (P = 0.0025). No significant differences were observed at any other measured IOP time points (Mann–Whitney U test). Compared to preoperative values, IOP was significantly lowered at all different time points. **P < 0.0001 as compared to preoperative value (Friedman test with the Conover method). IOP: Intraocular pressure; MicroShunt solo: Preserflo™ MicroShunt + Ologen™; MicroShunt + Phaco: Preserflo™ MicroShunt + Ologen™ + Phacoemulsification; Preop: Preoperative; D: Day; W: Week; M: Month; ns: not significant

Figure 3

Comparison of the mean intraocular pressure (IOP) lowering from preoperative values in Preserflo^TM MicroShunt + Ologen^TM (MicroShunt-solo) and Preserflo^TM MicroShunt + Ologen^TM + Phacoemulsification (MicroShunt + Phaco) groups. *p < 0.0001, **p < 0.05. Statistical significance was determined using the Mann–Whitney test. IOP: Intraocular pressure

Figure 4

Mean number of ocular hypotensive medications over the course of follow-up. Statistical significance was determined using the Mann–Whitney test. Preop: Preoperative; ns: Not-significant; MicroShunt-solo: Preserflo^TM MicroShunt + Ologen^TM; MicroShunt + Phaco: Preserflo^TM MicroShunt + Ologen^TM + Phacoemulsification

Figure 5

Mean intraocular pressure (IOP) (a) and mean IOP lowering (b) over the course of follow-up in the eyes that did not undergo previous glaucoma surgery. The vertical bars represent the 95% confidence interval. (a) A comparison of mean IOP between the eyes that underwent MicroShunt-solo and those that underwent MicroShunt + phacoemulsification (MicroShunt + Phaco) surgery. The preoperative mean IOP was significantly lower in the MicroShunt + Phaco group. No significant differences were observed at any other measured IOP time points (Mann–Whitney U test). IOP was significantly lowered at all different time points compared to preoperative values (*p < 0.0001, Friedman test with the Conover method). (b) Comparison of the mean IOP lowering from preoperative values in MicroShunt-solo and MicroShunt + Phaco groups. Statistical significance was determined using the Mann–Whitney test (†p < 0.0001, ‡p < 0.05). IOP: Intraocular pressure; MicroShunt-solo: Preserflo^TM MicroShunt + Ologen^TM; MicroShunt + Phaco: Preserflo^TM MicroShunt + Ologen^TM + Phacoemulsification; Preop: Preoperative; D: Day; W: Week; M: Month; ns: Not Significant