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Background <p>The XEN Gel Stent implantation using the traditional technique has demonstrated good efficacy and an acceptable safety profile. However, it is associated with intensive postoperative management due to high bleb needling and revision rates. The aim of this study is to assess the efficacy and safety of XEN63 Gel Stent implantation using a open-conjunctiva technique.</p> Methods <p>A multicentre retrospective chart review of consecutive patients who underwent XEN63 implantation using an open conjunctiva technique between 2023 and 2024 in the two University Eye centers was conducted. Only patients with at least 12 months of follow-up were included. Patient demographics, preoperative and postoperative clinical data were collected. Study variables were analyzed using Student’s t-test and Mann–Whitney U test. All tests were two-tailed, and statistical significance was defined for <i>p</i> &lt; 0.05. Kaplan–Meier survival analysis was used to estimate the probability of surgical success.</p> Results <p>A total of 119 patients with open-angle glaucoma, without previous glaucoma surgery, who underwent XEN63 implantation with open conjunctiva as a stand-alone procedure or combined with cataract surgery were included. Mean IOP decreased from 20.06 ± 5.91 mmHg at baseline to 10.94 ± 3.90 mmHg at postoperative month 12 (<i>p</i> &lt; 0.001) and mean number of medications decreased from 2.84 ± 0.82 preoperatively to 0.18 ± 0.65 at 12 months (<i>p</i> &lt; 0.001). Qualified success rates ranged from 78.9% to 58.8%, whereas complete success rates ranged from 73.1% to 55.5%, according to different defined criteria. During the follow-up, 13.4% of the eyes required one or more needling and 10% needed bleb revision or secondary glaucoma surgery.</p> Conclusions <p>Open-conjunctiva XEN63 Gel Stent implantation resulted in significant reductions in IOP and medication burden during a short-term follow-up, with a favorable safety profile and low postoperative intervention rates, in both stand-alone and combined procedures.</p>

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Efficacy and safety of XEN63 gel implant with open conjunctiva technique

  • 期刊论文

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  • 发表日期：

    2026年8月5日

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  • Luca M. Rossetti,
  • Maurizio Digiuni,
  • Benedetta Colizzi,
  • Amir A. Aminoleslami,
  • Gabriele Corsini,
  • Matilde Bartoccini,
  • Lily Chacra,
  • Paolo Radice,
  • Dario Romano

摘要

Background

The XEN Gel Stent implantation using the traditional technique has demonstrated good efficacy and an acceptable safety profile. However, it is associated with intensive postoperative management due to high bleb needling and revision rates. The aim of this study is to assess the efficacy and safety of XEN63 Gel Stent implantation using a open-conjunctiva technique.

Methods

A multicentre retrospective chart review of consecutive patients who underwent XEN63 implantation using an open conjunctiva technique between 2023 and 2024 in the two University Eye centers was conducted. Only patients with at least 12 months of follow-up were included. Patient demographics, preoperative and postoperative clinical data were collected. Study variables were analyzed using Student’s t-test and Mann–Whitney U test. All tests were two-tailed, and statistical significance was defined for p < 0.05. Kaplan–Meier survival analysis was used to estimate the probability of surgical success.

Results

A total of 119 patients with open-angle glaucoma, without previous glaucoma surgery, who underwent XEN63 implantation with open conjunctiva as a stand-alone procedure or combined with cataract surgery were included. Mean IOP decreased from 20.06 ± 5.91 mmHg at baseline to 10.94 ± 3.90 mmHg at postoperative month 12 (p < 0.001) and mean number of medications decreased from 2.84 ± 0.82 preoperatively to 0.18 ± 0.65 at 12 months (p < 0.001). Qualified success rates ranged from 78.9% to 58.8%, whereas complete success rates ranged from 73.1% to 55.5%, according to different defined criteria. During the follow-up, 13.4% of the eyes required one or more needling and 10% needed bleb revision or secondary glaucoma surgery.

Conclusions

Open-conjunctiva XEN63 Gel Stent implantation resulted in significant reductions in IOP and medication burden during a short-term follow-up, with a favorable safety profile and low postoperative intervention rates, in both stand-alone and combined procedures.