Long-term outcomes of Mitomycin-C augmented trabeculectomy using subconjunctival injections versus soaked sponges: a randomised controlled trial.

PURPOSE: To compare the safety and efficacy of subconjunctival injection of Mitomycin C(MMC) with sponge-applied MMC during trabeculectomy. METHODS: This prospective, randomised, interventional study was conducted on consecutive patients with uncontrolled glaucoma. 137 patients were randomised 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 ± 13.3 mmHg & 34.17 ± 10.6 mmHg in group 1 & 2 respectively, which reduced to 11.34 ± 3.7& 12.57 ± 4.7 mmHg(6 months),11.97 ± 4.2 & 13.60 ± 5.3 mmHg(1 year),12.42 ± 4.4 & 11.77 ± 2.8 mmHg (2 years) &11.25 ± 3.2 & 11.81 ± 3.2 mmHg 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.