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Effectiveness and Safety of Mitomycin C in Deep Sclerectomy with the Esnoper Clip Implant: A Case Series Study
Rachid Bouchikh-El Jarroudi1,2,3, Alina-Dana Baxant4, Pavel Studeny4
1Service of Ophthalmology, Germans Trias i Pujol University Hospital, 08916 Badalona, Spain.
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.
Insights
This study found that mitomycin C (MMC) did not improve intraocular pressure (IOP) outcomes in deep sclerectomy with Esnoper Clip for glaucoma patients. No increased safety concerns were noted with MMC use.
Area of Science:
- Ophthalmology
- Glaucoma Surgery
- Surgical Innovation
Background:
- Uncontrolled primary open-angle glaucoma presents a significant challenge in managing intraocular pressure (IOP).
- Deep Sclerectomy with the Esnoper Clip implant is a surgical option for glaucoma management.
- The role of perioperative mitomycin C (MMC) in enhancing outcomes for this procedure requires further investigation.
Purpose of the Study:
- To evaluate the effectiveness and safety of Deep Sclerectomy with the Esnoper Clip implant.
- To compare outcomes with and without the use of mitomycin C (MMC) in uncontrolled primary open-angle glaucoma.
- To provide evidence on intraocular pressure (IOP) reduction and complication rates.
Main Methods:
- A multicentric, retrospective case series comparing MMC and non-MMC groups.
- Inclusion of patients with uncontrolled primary open-angle glaucoma undergoing Deep Sclerectomy with Esnoper Clip.
- Assessment of complete and qualified success probabilities at 12 months post-surgery, alongside safety monitoring.
Main Results:
- Complete success probability was 62.2% with MMC vs. 80.5% without (p=0.001) at 12 months.
- Qualified success probability was similar between groups: 84.7% (MMC) vs. 85.7% (non-MMC) (p=0.188).
- No significant difference in complication rates was observed between the MMC and non-MMC groups (p=0.286).
Conclusions:
- Mitomycin C (MMC) did not demonstrate a significant benefit in improving IOP one year after Deep Sclerectomy with Esnoper Clip for uncontrolled primary open-angle glaucoma.
- The safety profile of the procedure was not negatively impacted by the use of MMC.
- Further research is warranted to confirm these findings and evaluate long-term safety and efficacy.
