e6cfc1d0185ea89fc0d9848eda15c9f6 320314.pdf ce117b84db287fe4704a86d60ea89f94a6c4b0b5 320314.pdf 98c3db99d5d457833352e8beb968f281ac5d8725060ddf73ad2f6afa3dbac758 320314.pdf Title: Effectiveness and Safety of Mitomycin C in Deep Sclerectomy with the Esnoper Clip Implant: A Case Series Study Subject: 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.20pt Keywords: glaucoma; Deep Sclerectomy; Esnoper Clip; mitomycin C; fibrosis; safety Author: Rachid Bouchikh-El Jarroudi, Alina-Dana Baxant, Pavel Studeny, Kolbe Roche Fernández, Adrian Sanchez-Fortun-Sanchez, Martin Pencak, Jessica Botella-Garcia, Jordi Loscos-Arenas, Antoni Sabala Llopart, Sebastian Videla and Pau Romera-Romero Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25; modified using OpenPDF 1.4.2 CreationDate: Thu Aug 28 11:49:16 2025 CEST ModDate: Thu Aug 28 12:13:29 2025 CEST Custom Metadata: yes Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 13 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 1851681 bytes Optimized: no PDF version: 1.5 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- PGGTOT+URWPalladioL-Ital Type 1 Custom yes yes yes 102 0 SODFOM+URWPalladioL-Bold Type 1 Custom yes yes yes 103 0 UYJHYJ+URWPalladioL-Roma Type 1 Custom yes yes yes 104 0 UIEKTG+CMSY10 Type 1 Builtin yes yes yes 178 0 LJBBAH+PalatinoLinotype TrueType WinAnsi yes yes no 173 0 JLZORU+EURM10 Type 1 Builtin yes yes yes 205 0 WBVKDJ+URWPalladioL-BoldItal Type 1 Custom yes yes yes 237 0 LJBBAH+PalatinoLinotype TrueType WinAnsi yes yes no 224 0 LJBBAF+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 225 0 LJBBAH+PalatinoLinotype TrueType WinAnsi yes yes no 217 0 LJBBAH+PalatinoLinotype TrueType WinAnsi yes yes no 232 0 LJBBAF+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 233 0 LJBBAH+PalatinoLinotype TrueType WinAnsi yes yes no 282 0 LJBBAH+PalatinoLinotype TrueType WinAnsi yes yes no 288 0 LJBBAH+PalatinoLinotype TrueType WinAnsi yes yes no 294 0 VVNFBF+VnURWPalladioL Type 1 Custom yes yes yes 389 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2025-10-15 03:53:05 CEST RepresentationInformation: 320314.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2025-10-14 10:11:48 CEST Size: 1851681 Format: PDF Version: 1.5 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 450 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: ViewerPreferences: HideToolbar: false HideMenubar: false HideWindowUI: false FitWindow: true CenterWindow: false DisplayDocTitle: false NonFullScreenPageMode: UseNone Direction: L2R ViewArea: CropBox ViewClip: CropBox PrintArea: CropBox PageClip: CropBox PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Item: Title: Materials and Methods Children: Item: Title: Study Design Item: Title: Study Population Item: Title: Surgical Technique Item: Title: Endpoints Item: Title: Statistical Analysis Item: Title: Results Children: Item: Title: Baseline Characteristics Item: Title: Effectiveness of MMC Item: Title: Safety Item: Title: Discussion Item: Title: Conclusions Item: Title: References Info: Title: Effectiveness and Safety of Mitomycin C in Deep Sclerectomy with the Esnoper Clip Implant: A Case Series Study Author: Rachid Bouchikh-El Jarroudi, Alina-Dana Baxant, Pavel Studeny, Kolbe Roche Fernández, Adrian Sanchez-Fortun-Sanchez, Martin Pencak, Jessica Botella-Garcia, Jordi Loscos-Arenas, Antoni Sabala Llopart, Sebastian Videla and Pau Romera-Romero Subject: 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. 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