Keidel Leonie F, Gehrke Miranda, Kassumeh Stefan, Buhl Lara, Priglinger Siegfried G, Mackert Marc J
Department of Ophthalmology, LMU University Hospital, LMU Munich, Mathildenstr. 8, 80336 Munich, Germany.
J Clin Med. 2025 Aug 25;14(17):6000. doi: 10.3390/jcm14176000.
: This work aims to clarify whether the subtenon use of the sodium hyaluronate product Healaflow in filtrating surgery with PreserFlo MicroShunt positively influences the early postoperative course in terms of control of intraocular pressure, hypotony, and needling rate. : A retrospective, randomized controlled, interventional, single-center trial was performed at the Ludwig Maximilians-University Munich from January 2024 to July 2024. Only patients with primary open angle glaucoma (POAG) were included. In all patients, a complete ophthalmological examination including best corrected visual acuity (BCVA), automated refraction, and Goldman tonometry was performed at 2 days, 1-4 and 5-8 weeks, and 3-4 and 5-6 months after surgery. Healaflow was injected underneath the tenon during filtrating surgery with PreserFlo MicroShunt in addition to mitomycin C (MMC). The Healaflow group was compared to a control group with POAG patients in which Healaflow was not used during surgery with PreserFlo MicroShunt and MMC. : A total of 45 eyes of 45 patients were included, with 20 eyes in the Healaflow group and 25 eyes in the control group. In both groups, a significant reduction in IOP and medication could be observed: complete surgical success (IOP ≥ 6 mm Hg and ≤17 mm Hg, without surgical complications or complete loss of vision) was reached in 88% of patients in the Healaflow group at the last follow-up. In 95% of patients in the control group, complete success could be observed. The success rates did not significantly differ between the two groups ( = 0.568). Hypotony rates were 35% in the Healaflow and 12% in the control group after two days ( = 0.083); the rates equalized after 1-4 weeks ( = 1). Needling rates were comparable between both groups (25% versus 20%, = 0.731). : PreserFlo MicroShunt implantation with MMC was equally effective in terms of reduction in IOP and medication in both scenarios with additional or without the use of Healaflow. Postoperative hypotony and needling rates did not significantly differ between the two groups. The additional effects of Healaflow on anti-scarring and maintaining space are likely too minimal to cause significant differences in IOP or medication when already treated with MMC.
这项工作旨在阐明，在使用PreserFlo微型分流器进行滤过手术时，在眼球筋膜下使用透明质酸钠产品Healaflow，在控制眼压、低眼压和针刺率方面是否对术后早期病程产生积极影响。
2024年1月至2024年7月在慕尼黑路德维希-马克西米利安大学进行了一项回顾性、随机对照、干预性单中心试验。仅纳入原发性开角型青光眼（POAG）患者。所有患者在术后2天、1 - 4周和5 - 8周以及3 - 4个月和5 - 6个月进行了包括最佳矫正视力（BCVA）、自动验光和Goldmann眼压测量在内的全面眼科检查。在使用PreserFlo微型分流器进行滤过手术时，除丝裂霉素C（MMC）外，在眼球筋膜下注射Healaflow。将Healaflow组与一组POAG患者对照组进行比较，该对照组在使用PreserFlo微型分流器和MMC进行手术时未使用Healaflow。
共纳入45例患者的45只眼，Healaflow组20只眼，对照组25只眼。两组均观察到眼压和用药量显著降低：在最后一次随访时，Healaflow组88%的患者达到完全手术成功（眼压≥6 mmHg且≤17 mmHg，无手术并发症或完全失明）。对照组95%的患者观察到完全成功。两组成功率无显著差异（P = 0.568）。术后两天Healaflow组低眼压发生率为35%，对照组为12%（P = 0.083）；1 - 4周后发生率相等（P = 1）。两组针刺率相当（25%对20%，P = 0.731）。
在使用或不使用Healaflow的两种情况下，植入PreserFlo微型分流器并联合MMC在降低眼压和用药方面同样有效。两组术后低眼压和针刺率无显著差异。当已经使用MMC治疗时，Healaflow在抗瘢痕形成和维持空间方面的额外作用可能太小，以至于在眼压或用药方面不会导致显著差异。
