Effectiveness and Safety of Mitomycin C in Deep Sclerectomy with the Esnoper Clip Implant

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,...

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Detalles Bibliográficos
Autores: Bouchikh-El Jarroudi, Rachid|||0000-0002-7240-8246, Baxant, Alina-Dana, Studeny, Pavel, Roche Fernández, Kolbe, Sanchez-Fortun-Sanchez, Adrian, Pencak, Martin, Botella-Garcia, Jessica|||0000-0003-0828-9243, Loscos Arenas, Jordi|||0000-0002-8902-0547, Sabala-Llopart, Antoni|||0000-0003-0002-3950, Videla, Sebastián|||0000-0001-5049-1379, Romera-Romero, Pau|||0000-0003-1699-6378
Tipo de recurso: artículo
Fecha de publicación:2025
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:320314
Acceso en línea:https://ddd.uab.cat/record/320314
https://dx.doi.org/urn:doi:10.3390/jcm14176085
Access Level:acceso abierto
Palabra clave:Glaucoma
Deep Sclerectomy
Esnoper Clip
Mitomycin C
Fibrosis
Safety
Descripción
Sumario: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.