Effectiveness and Safety of Mitomycin C in Deep Sclerectomy with the Esnoper Clip Implant: A Case Series Study

Abstract

Objective: The objective was to provide evidence on the effectiveness (intraocular pressure, IOP) and safety of Deep Sclerectomy with the Esnoper Clip implant with and without the use of mitomycin C (MMC) in uncontrolled primary open-angle glaucoma. Methods: This was a multicentric, retrospective, consecutive case series study undertaken as a collaboration between University Hospital Trias i Pujol, Spain, and University Hospital Kralovske Vinohrady, Czech Republic. The IOP reduction was compared between patients who underwent Deep Sclerectomy with the Esnoper Clip implant, where the antifibrotic agent mitomycin C was used perioperatively (MMC group), and patients who underwent Deep Sclerectomy with Esnoper Clip implants where mitomycin C was not used either peri- or postoperatively (non-MMC group). At the end of the study (12 months after surgery), complete success probability (defined as an IOP <21 mmHg without medication) and qualified success probability (defined as an IOP <21 mmHg with or without medication) were assessed. Safety was based on postoperative complications. A descriptive and exploratory analysis was performed. Results: Between January 2017 and June 2019, a total of 72 consecutive patients (40 women and 32 men; age [median (range)] 70 (39–90)) with uncontrolled primary open-angle glaucoma who underwent Deep Sclerectomy with an Esnoper Clip implant were included. Of these, 78 eyes were included: 44 eyes (38 patients) in the MMC group and 34 eyes (34 patients) in the non-MMC group. At the end of the study (38 and 32 eyes, respectively), the complete success probabilities (95% confidence interval) were 62.2% (51.5–75.2%) and 80.5% (69.5–93.2%), p-value: 0.001; qualified success probability (95% confidence interval): 84.7% (76.6–93.7%) and 85.7% (75.8–97%), p-value: 0.188; and complications (total): 36 and 24, p-value: 0.286. Conclusions: In this case series study, the use of mitomycin C in Deep Sclerectomy with the Esnoper Clip implant for patients with uncontrolled primary open-angle glaucoma does not appear to improve IOP one year after surgery. No safety issues related to mitomycin C were observed. Further study is needed to confirm the effectiveness and to assess long-term safety.