Effectiveness and Safety of Mitomycin C in Deep Sclerectomy with the Esnoper Clip Implant : A Case Series Study
Bouchikh-El Jarroudi, Rachid (Universitat Autònoma de Barcelona. Departament de Medicina)
Baxant, Alina-Dana (University Hospital Kralovske Vinohrady (Pagra, República Txeca))
Studeny, Pavel (University Hospital Kralovske Vinohrady (Pagra, República Txeca))
Roche Fernández, Kolbe (Institut Germans Trias i Pujol. Banc de Sang i Teixits)
Sanchez-Fortun-Sanchez, Adrian (Institut Germans Trias i Pujol. Banc de Sang i Teixits)
Pencak, Martin (University Hospital Kralovske Vinohrady (Pagra, República Txeca))
Botella-Garcia, Jessica (Institut Germans Trias i Pujol. Banc de Sang i Teixits)
Loscos Arenas, Jordi (Institut Germans Trias i Pujol. Banc de Sang i Teixits)
Sabala Llopart, Antoni (Institut Germans Trias i Pujol. Banc de Sang i Teixits)
Videla, Sebastián (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)
Romera-Romero, Pau (Universitat Autònoma de Barcelona. Departament de Cirurgia)

Date:	2025
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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Glaucoma ; Deep Sclerectomy ; Esnoper Clip ; Mitomycin C ; Fibrosis ; Safety
Published in:	Journal of clinical medicine, Vol. 14 (august 2025) , ISSN 2077-0383

DOI: 10.3390/jcm14176085
PMID: 40943846

13 p, 1.8 MB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Research articles
Articles > Published articles