Long-term Outcomes Of Mitomycin-C Augmented Trabeculectomy using Subconjunctival Injections Versus Soaked Sponges: A Randomized Controlled Trial

Abstract

Purpose: To compare the safety and efficacy of subconjunctival injection of Mitomycin C(MMC) with sponge-applied MMC during trabeculectomy. Methods: This prospective, randomized, interventional study was conducted on consecutive patients with uncontrolled glaucoma. 137 patients were randomized into an Injection group(Group 1,n=66) and a sponge group(Group 2,n=71). Trabeculectomy was performed in all patients who were followed up on days 1, 15, 30, 3 months,6 months,1 year,2 years & 3 years postoperatively. Baseline & follow-up visits were compared to find out difference in the number of antiglaucoma medications (AGM ), Intraocular pressure(IOP), and Best Corrected Visual Acuity(BCVA).In Group 1, the surgeon used MMC 0.2 mg/ml as subconjunctival injection and two separate semicircular surgical sponges soaked with MMC solution of 0.2 mg/mL were inserted subconjunctivally in Group 2. Results:Mean preop IOP was 34.21±13.3mmHg& 34.17±10.6mmHg in group 1&2 respectively,which reduced to 11.34±3.7& 12.57±4.7mmHg(6 months),11.97±4.2& 13.60 ±5.3mmHg(1year),12.42±4.4& 11.77±2.8 mmHg(2years)&11.25±3.2&11.81±3.2mmHg at final visit(P<0.001 in both groups)with no significant difference between the groups.The mean number of preoperative AGM was 2.32±0.7&2.32±0.8 in group1&2 respectively which reduced to 0.78±0.9(P<0.001)&1.13±1.1(P=0.930)at 3 years.Overall success rates were 75.3% in group 1 and 70.7% in group 2 at 3 years(p=0.512). Postoperative complications and the final post-operative visual outcomes were similar between the groups. Conclusion: Subconjunctival Injection of MMC is as safe and effective as sponge application with comparable surgical outcomes and complications in the long term.