Julio Gemma, Larena Raquel, Mármol Marta, Soldevila Anna, Canut María Isabel, Pavan Josip, Barraquer Rafael I
Centro de Oftalmología Barraquer, 08021 Barcelona, Spain.
Institut Universitari Barraquer, Universitat Autònoma de Catalunya, 08021 Barcelona, Spain.
J Clin Med. 2024 Jun 11;13(12):3406. doi: 10.3390/jcm13123406.
To assess intraocular pressure (IOP) changes and complications after XEN45 implants in medically controlled eyes (MCE) vs. medically uncontrolled eyes (MUE). 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. 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 ( > 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) ( = 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. 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.
评估在药物控制的眼睛(MCE)与药物未控制的眼睛(MUE)中植入XEN45后眼压(IOP)的变化及并发症。在一家三级转诊医院进行的一项回顾性研究,研究对象为接受局部药物治疗的轻至中度原发性开角型青光眼(POAG)病例,包括32只眼压<21 mmHg的眼睛(MCE组)和30只眼压≥21 mmHg的眼睛(MUE组)。使用Kaplan-Meier分析的成功标准为末次随访时无需药物治疗眼压<21 mmHg(完全成功)或使用药物少于术前(合格成功),且无新的手术或未解决的低眼压情况。两组术前未发现显著差异。随访结束时(分别为平均26.1±15.6个月和28.3±15.3个月),MCE组平均眼压为15.6±3.8 mmHg,MUE组为15.1±4.1 mmHg(>0.05;Mann-Whitney检验)(Mann-Whitney检验,P = 0.414)。该装置在两组中均在24小时时导致眼压显著降低。此后,MCE组眼压有显著升高趋势,在1个月时恢复至基线值并维持至随访结束。相比之下,MUE组在首次眼压降低后眼压值趋于相似。生存分析未发现相关并发症,两组之间也无显著差异。XEN45在MCE组和MUE组中均能提供稳定的眼压控制,中期无重要并发症。MCE组在眼压先降低后升高,术后1个月恢复至基线值。导致眼压升高至基线值的稳态机制及其与失败病例的关系仍有待阐明。