A Randomized Clinical Trial to Compare the Efficacy and Safety of Absorbable Biosynthetic Sodium Hyaluronate scleral Implant with Mitomycin-C in Trabeculectomy: A One Year Study At KLES Dr. Prabhakar Kore Hospital & MRC, Belagavi

Abstract

BJECTIVE ABSTRACT Over the years, the gold standard and widely accepted surgical procedure for intraocular pressure (IOP) reduction in patients with medically uncontrolled glaucoma has been trabeculectomy. However, development of fibrosis because of progressive fibroblast proliferation and collagen deposition at the site of the filtration bleb causes trabeculectomy failure leading to poor IOP control with subsequent progressive optic nerve damage. In addition to steroid therapy, anti-fibrotics such as 5-Fluorouracil (5-FU) and Mitomycin-C (MMC), have been widely used both for wound modulation to improve the surgical success by preventing bleb failure but had postoperative complications. Sodium Hyaluronate was also considered as a possible scleral implant due to its high molecular weight and steric hindrance. Therefore, this study was aimed at comparing the outcomes of a cross-linked sodium hyaluronate (CLSH) (HealaFlow ® ) that provides a slowly re-absorbable injectable viscoelastic scleral implant and anti- metabolite Mitomycin – C (MMC) as an adjuvant during trabeculectomy in glaucoma patients at a Tertiary Care Hospital located in Southern India. METHODOLOGY A Randomized Control Trial was conducted on 60 eyes of 51 patients who were posted for trabeculectomy were randomized into two groups: CLSH group (study group) and low dose MMC (0.1mg/ml for 2 minutes) group (control group) with or without cataract surgery. v RESULTS Out of the 60 eyes of 51 patients, majority were of 61-70 years with a M:F ratio of 1.72:1. A total of 76.67% patients had Primary Open Angle Glaucoma (POAG) and 78.33% patients underwent trabeculectomy with lens extraction. The pre-operative IOP was 23.60±13.81mmHg in the CLSH group and 25.81±11.01mmHg in the MMC group which led to a 53.94% and 53.23% reduction of IOP respectively leading to 10.87±2.43mmHg and 12.07±4.25mmHg of IOP after 6 months, net reduction being similar in both groups. In both categories, the Best Corrected Visual Acuity (BCVA) either remained same or improved. Mostly the bleb had 25% central area, 25% peripheral area with moderate elevation and mild vascularity. The outcome in both groups was similar i.e. 90% complete success and 100% total success. Therefore, no difference was seen between CLSH and MMC in terms of outcome. Complications like hyphema and sub-conjunctival hemorrhage under the bleb occurred equally in both the groups. CONCLUSION AND INTERPRETATION CLSH implant and low dose MMC (0.1mg/ml x 2 minutes) were found to be associated with equally good control of IOP, equal stabilization of visual acuity, well- functioning, well elevated and vascularised blebs, with minimal acceptable complications. Both can be used safely with similar efficacy as an adjuvant in trabeculectomy to prevent bleb failure.