Nicula Cristina, Nicula Dorin, Rednik Anca, Bulboacă Adriana Elena, Bolboacă Sorana D
Department of Ophthalmology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.
Oculens Clinic, Calea Turzii, Cluj-Napoca, Romania.
Arch Med Sci. 2019 Nov 25;19(4):1069-1079. doi: 10.5114/aoms.2019.89971. eCollection 2023.
The study aimed to evaluate the efficacy and safety in 4-year follow-up of Ex-PRESS P-200 mini-shunt implantation versus standard trabeculectomy.
A single-center retrospective study on patients diagnosed with open-angle glaucoma with failed medical treatment and who underwent Ex-PRESS device implantation or standard trabeculectomy was conducted. Seventy-three eyes were included in the analysis, 33 with Ex-PRESS P-200 implantation and 40 with standard trabeculectomy.
Significant decreases in the intraocular pressure (IOP) were observed after surgery and at all follow-ups in both groups ( < 0.001) with no significant difference between the two groups ( > 0.40). No significant differences with regard to post-operative medications were observed ( > 0.10). Excepting the 3-year follow-up, when just a borderline significant difference regarding the visual acuity between the Ex-PRESS and standard trabeculectomy group was observed ( = 0.0504), the Ex-PRESS groups showed significantly better visual acuity at 6 weeks ( = 0.0324), 1 year ( = 0.0168), 2 years ( = 0.0162), and 4 years ( = 0.0111). Hypotony occurred more frequently among the Ex-PRESS group, while cataract occurred more frequently among those with standard trabeculectomy, without significant differences between groups ( > 0.09). No difference in hazard of failure was observed between interventions (HR = 0.72, = 0.523).
Both procedures provided good control of IOP and decreased the number of postoperative medications. The advantage of the Ex-PRESS shunt is the better visual acuity, but its main limitation is the cost.
本研究旨在评估Ex-PRESS P-200微型分流植入术与标准小梁切除术4年随访期内的疗效和安全性。
对诊断为药物治疗失败的开角型青光眼且接受Ex-PRESS装置植入术或标准小梁切除术的患者进行单中心回顾性研究。73只眼纳入分析，其中33只眼接受Ex-PRESS P-200植入术，40只眼接受标准小梁切除术。
两组术后及各随访期眼压均显著降低（<0.001），两组间无显著差异（>0.40）。术后用药方面未观察到显著差异（>0.10）。除3年随访时Ex-PRESS组与标准小梁切除术组在视力方面仅观察到临界显著差异（=0.0504）外，Ex-PRESS组在6周（=0.0324）、1年（=0.0168）、2年（=0.0162）和4年（=0.0111）时视力显著更好。低眼压在Ex-PRESS组中更频繁发生，而白内障在标准小梁切除术患者中更频繁发生，两组间无显著差异（>0.09）。两种干预措施在失败风险方面未观察到差异（HR = 0.72，=0.523）。
两种手术均能良好控制眼压并减少术后用药数量。Ex-PRESS分流术的优势在于视力更好，但其主要局限在于成本。
