A Randomized Controlled Trial Comparing Subconjunctival Injection to Direct Scleral Application of Mitomycin C in Trabeculectomy.

Abstract

To compare the efficacy of intraoperative scleral application with subconjunctival injection of mitomycin C (MMC) in trabeculectomy. Prospective, randomized, interventional study. This study took place in a single clinical practice in an academic setting. Patients had medically uncontrolled glaucoma as indicated by high intraocular pressure (IOP), worsening visual field, or optic nerve head changes in whom primary trabeculectomy was indicated. Patients were older than 18 years with medically uncontrolled glaucoma and no history of incisional glaucoma surgery. Patients were randomized to MMC delivered by preoperative subconjunctival injection or by intraoperative direct scleral application using surgical sponges during trabeculectomy. Comprehensive eye examinations were conducted at 1 day, 1 week, 6 weeks, 3 months, and 6 months postoperatively. Subconjunctival 5-fluorouracil injections were given postoperatively, as needed. The primary outcome was the proportion of patients who demonstrated IOP of <21 mm Hg and ≥30% reduction in IOP from baseline. Secondary outcome measures included the number of IOP-lowering medications, bleb morphology using the Indiana Bleb Appearance Grading Scale, and complication rates. Participants (n = 100) were randomized into groups matched for baseline demographics, glaucoma status, and baseline IOP. At 6 months, there were no significant differences between the injection (n = 38) and sponge (n = 40) groups in surgical success (P = .357), mean IOP (P = .707), number of glaucoma medications (P = 1.000), bleb height (P = .625), bleb extension (P = .216), bleb vascularity (P = .672), or complications rates. Both techniques of MMC delivery (subconjunctival injection and direct scleral application) resulted in comparable surgical outcomes and bleb morphologies.