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. 2024 Jun 11;13(12):3406.
doi: 10.3390/jcm13123406.

XEN45 Implant in Medically Controlled vs. Uncontrolled Eyes-Differential IOP Changes in Real-Life Conditions

Gemma Julio  1   2 , Raquel Larena  1   2 , Marta Mármol  1   2 , Anna Soldevila  1   2 , María Isabel Canut  1   2   3 , Josip Pavan  4 , Rafael I Barraquer  1   2   5
Affiliations

XEN45 Implant in Medically Controlled vs. Uncontrolled Eyes-Differential IOP Changes in Real-Life Conditions

Gemma Julio et al. J Clin Med. .

Abstract

Background: To assess intraocular pressure (IOP) changes and complications after XEN45 implants in medically controlled eyes (MCE) vs. medically uncontrolled eyes (MUE). Methods: A retrospective study, in a tertiary referral hospital, on mild-to-moderate primary open-angle glaucoma (POAG) cases under topical medication, including 32 eyes with IOP < 21 mmHg (MCE group) and 30 eyes with IOP ≥ 21 mmHg (MUE group). The success criteria using Kaplan-Meier analysis was IOP < 21 mmHg without medications (complete success) or fewer drugs than preoperatively (qualified success) at the last visit, without new surgery or unresolved hypotony. Results: No significant preoperative differences were found between the groups. The mean IOP was 15.6 ± 3.8 mmHg in MCE and 15.1 ± 4.1 mmHg in the MUE group (p > 0.05; Mann-Whitney test) at the end of the follow-up (mean of 26.1 ± 15.6 months and 28.3 ± 15.3 months, respectively) (p = 0.414, Mann-Whitney Test). The device caused a significant IOP reduction at 24 h in both groups. Thereafter, the MCE group significantly tended to increase IOP, recovering baseline values at 1 month and maintaining them until the end of the follow-up. In contrast, in the MUE group, the IOP values tended to be similar after the first reduction. No relevant complications and no significant differences between the groups in the survival analysis were found. Conclusions: XEN45 provided stable IOP control in both the MCE and MUE group without important complications in the medium term. The IOP increasing in the MCE group, after a prior decrease, led to restored baseline values 1 month after surgery. The homeostatic mechanism that causes the rise in the IOP to baseline values and its relationship with failure cases remains to be clarified.

Keywords: MIGS; XEN45 implant; intraocular pressure; minimally invasive glaucoma surgery; primary open-angle glaucoma; survival analysis.

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Conflict of interest statement

The authors declared no potential conflicts of interest concerning the research, authorship, and/or publication of the article.

Figures

Figure 1
Figure 1
IOP changes in each eye.
Figure 2
Figure 2
IOP changes during follow-up. Bars represent the standard deviation, respectively. Pre-op: baseline IOP; d: day; w: week; m: month.
Figure 3
Figure 3
Changes in the number of ocular hypotensive topical medications in each patient.
Figure 4
Figure 4
Survival analysis. Top: Survival analysis (success: complete and qualified success). Bottom: Survival analysis (success: only complete success). MCE: medically controlled eyes; MUE: medically uncontrolled eyes.
See this image and copyright information in PMC

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