Department of Ophthalmology, KLE Academy of Higher Education and Research, Belagavi, Karnataka, India.
Indian J Ophthalmol. 2021 May;69(5):1135-1141. doi: 10.4103/ijo.IJO_2462_20.
Patients with glaucoma undergoing trabeculectomy develop bleb cicatrix causing poor postoperative intraocular pressure (IOP) control and low success rates. Several approaches have been explored over the years for better outcomes. This study assesses the safety, efficacy, and outcome of trabeculectomy with HealaFlow (Anteis S. A, Geneva, Switzerland), a high-molecular-weight cross-linked hyaluronic acid viscoelastic gel, and comparing it with the antimetabolite Mitomycin-C (MMC).
A prospective, interventional, case-controlled study conducted at a tertiary care hospital in Southern India on 60 eyes of patients requiring trabeculectomy divided in two groups - HealaFlow scleral implant and adjuvant low-dose MMC (0.1 mg/mL). Postoperative IOP reduction along with bleb morphology was assessed over follow-up at 1 week, 1 month, 3 months, 6 months, and 12 months.
Preoperatively IOP in the two groups was statistically similar. Postoperative IOP on day 1 had statistically significant reduction in both groups with greater reduction in MMC group. However, by 12 months, the IOP reduction was statistically similar in both groups, i.e., 46.24% (to 11.04 ± 2.55 mmHg) and 54.47% (to 11.99 ± 3.37 mmHg) in HealaFlow group and MMC group, respectively (P > 0.05). The bleb morphologies were similar and complications were seen equally, which resolved by 4 weeks. A complete success rate of 89.29% and a qualified success rate of 10.71% were observed equally in both groups.
Absorbable biosynthetic cross-linked hyaluronic acid and low-dose MMC are equally safe and efficacious in trabeculectomy with significant IOP reduction and good bleb morphology. Therefore, it is a novel substitute for MMC.
接受小梁切除术的青光眼患者会出现滤泡瘢痕，导致术后眼压（IOP）控制不佳和成功率低。多年来，已经探索了几种方法来获得更好的效果。本研究评估了使用 HealaFlow（Anteis S. A，瑞士日内瓦）进行小梁切除术的安全性、疗效和结果，HealaFlow 是一种高分子量交联透明质酸粘弹凝胶，并将其与抗代谢物丝裂霉素 C（MMC）进行比较。
在印度南部的一家三级护理医院进行了一项前瞻性、干预性、病例对照研究，共纳入 60 只需要进行小梁切除术的患者的眼睛，将其分为两组 - HealaFlow 巩膜植入物和辅助低剂量 MMC（0.1mg/mL）。在随访期间（术后 1 周、1 个月、3 个月、6 个月和 12 个月）评估术后 IOP 降低情况和滤泡形态。
两组患者术前的 IOP 统计学上相似。两组术后第 1 天的 IOP 均有统计学显著降低，MMC 组的降低更为显著。然而，到 12 个月时，两组的 IOP 降低情况统计学上相似，即 HealaFlow 组和 MMC 组分别为 46.24%（至 11.04±2.55mmHg）和 54.47%（至 11.99±3.37mmHg）（P>0.05）。滤泡形态相似，并发症同样出现，且在 4 周内得到解决。两组的完全成功率分别为 89.29%和 10.71%，定性成功率相等。
可吸收生物合成交联透明质酸和低剂量 MMC 在小梁切除术中同样安全有效，可显著降低 IOP，且滤泡形态良好。因此，它是 MMC 的一种新型替代品。
