Cross-linked hyaluronic acid viscoelastic scleral implant in trabeculectomy

PURPOSE: 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). METHODS: 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. RESULTS: 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. CONCLUSION: 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.