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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F25%3A43928826" target="_blank" >RIV/00064173:_____/25:43928826 - isvavai.cz</a>

Výsledek na webu

<a href="https://doi.org/10.3390/jcm14176085" target="_blank" >https://doi.org/10.3390/jcm14176085</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3390/jcm14176085" target="_blank" >10.3390/jcm14176085</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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 &lt;21 mmHg without medication) and qualified success probability (defined as an IOP &lt;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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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 &lt;21 mmHg without medication) and qualified success probability (defined as an IOP &lt;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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30207 - Ophthalmology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Journal of Clinical Medicine

ISSN

2077-0383

e-ISSN

2077-0383

Svazek periodika

14

Číslo periodika v rámci svazku

17

Stát vydavatele periodika

CH - Švýcarská konfederace

Počet stran výsledku

13

Strana od-do

6085

Kód UT WoS článku

001571370600001

EID výsledku v databázi Scopus

2-s2.0-105015956922