PDF(Pubmed)
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.
摘要：
背景：评估医学控制眼（MCE）与XEN45植入物后眼内压（IOP）的变化和并发症不受医学控制的眼睛（MUE）。方法:回顾性研究,在三级转诊医院，在局部用药的轻度至中度原发性开角型青光眼（POAG）病例中，其中IOP<21mmHg(MCE组)32只眼,IOP≥21mmHg(MUE组)30只眼。使用Kaplan-Meier分析的成功标准是：在最后一次就诊时，不使用药物（完全成功）或少于术前药物（合格成功）的IOP<21mmHg。没有新的手术或未解决的低张力。结果:两组术前差异无统计学意义。随访结束时，MCE组平均IOP为15.6±3.8mmHg，MUE组为15.1±4.1mmHg（p>0.05；Mann-Whitney检验）（平均26.1±15.6个月和28.3±15.3个月，分别)(p=0.414，曼-惠特尼检验)。在两组中,该装置在24小时引起IOP显著降低。此后,MCE组IOP明显升高,在1个月时恢复基线值，并维持至随访结束。相比之下,在MUE组中，在第一次降低后,IOP值趋于相似.无相关并发症，组间生存分析无显著差异。结论：XEN45在MCE和MUE组均提供稳定的IOP控制，中期无重要并发症。MCE组的IOP增加，在之前的下降之后，导致术后1个月基线值恢复。导致IOP上升至基线值的稳态机制及其与失败病例的关系仍有待澄清。
