Abstract
Purpose :
To study the safety and efficacy of intraoperative injection of Mitomycin (MMC) versus conventional sponge-applied MMC during double site phaco-trabeculectomy (PT) in a cohort of patients from Southern India
Methods :
POAG and PXFG patients were prospectively randomized to intra-op injection of 0.1ml of 0.1 mg/ml MMC or 2 sponges soaked in 0.4 mg/ml MMC applied for 2 minutes. Demographics, visual acuity (VA), intraocular pressure (IOP), number of glaucoma medications, post-op complications, interventions, additional surgery were collected at baseline, post-op: day 1, week 2, month 1, 3, and 6. Mean, T-test, or chi-square tests were performed. The surgeries were performed by multiple surgeons in a single center.
Results :
71 eyes were included: 36 injection group, and 35 sponge group. Pre-op IOP, number of glaucoma medications (2.3±0.4), and VA (6/24) was similar (p >0.418) between groups. Pre-operative IOP (mean mmHg±SD) was 22.8±7.0 in the injection group and 21.6±6.0 in the sponge group. At 6 months, IOP was decreased (P <0.001) in both groups to 13.3±2.6 (36.3%) in the injection and 16.3±3.4 (20.1%) in the sponge group and was lower (P <0.0001) in the injection group than in the sponge group. All patients in the injection group achieved complete or qualified surgical success at 6 months, defined as IOP<21 with or without medication and no complications, whereas only 42.8% of the patients in the sponge group had complete or qualified surgical success (P <0.001). 8% of patients in the injection group and 25% of patients in sponge group required one of more glaucoma medications postop (p = 0.05). Post-op vision was similar (p=.554) in both groups, and improved (p<.001) from baseline. Complications included two cases of hyphema and one case of endophthalmitis which all occurred in the sponge group.
Conclusions :
Subconjunctival injection of MMC during PT was safe and more effective than conventional sponge application of MMC with greater IOP reduction and more patients with surgical success. Longer follow-up of a larger cohort is needed to further characterize the efficacy and safety of this modality.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.