Collagen matrix vs mitomycin-C in trabeculectomy and combined phacoemulsification and trabeculectomy: a randomized controlled trial

Abstract

BackgroundAntifibrotic agents are commonly utilized to enhance the success rates of trabeculectomy. Novel approaches to further improve success rates and reduce the risks of complications are needed. The purpose of this study was to compare intraocular pressure (IOP)-lowering efficacy and safety of trabeculectomy or combined phacoemulsification and trabeculectomy with mitomycin-C (MMC) vs. Collagen Matrix (CM).MethodsA prospective, multicenter, randomized controlled trial was performed. Ninety-five eyes of 94 patients with uncontrolled glaucoma despite medical therapy, without previous incisional glaucoma surgery underwent trabeculectomy (85 eyes) or combined phacoemulsification and trabeculectomy (10 eyes) and were randomized to MMC or CM. One eye of each subject was analyzed. Patients were followed for 24 months. The criteria for complete success were IOP >5 and ≤21 mmHg with at least a 20% reduction below medicated baseline without additional glaucoma surgery or medications. The main outcome measures were complete success rates at 24 months with Kaplan-Meier analysis and incidence of adverse events.ResultsThe baseline IOPs were 20.4 ± 6.0 mmHg and 21.2 ± 6.1 (mean ± standard deviation, p = 0.49) on 3.2 ± 1.1 and 3.1 ± 1.0 medications (p = 0.53) compared to 11.8 ± 5.2 and 12.8 ± 3.7 (p = 0.36) on 0.5 ± 0.8 and 0.6 ± 1.0 medications (p = 0.63) at 2 years in the MMC and CM groups, respectively. Kaplan-Meier analysis demonstrated complete success rates were similar in both groups at 24 months: 38.4 ± 7.6% with MMC and 56.2 ± 7.9% with CM (mean ± standard error, p = 0.112, log rank test); however, a significantly higher incidence of failure due to persistent hypotony was observed with MMC (p = 0.002).ConclusionsUse of the CM implant at the time of trabeculectomy or combined phacoemulsification and trabeculectomy is associated with similar complete success rates compared to adjunctive MMC; however, the risk of persistent hypotony is higher with MMC.Trial registrationClinicalTrials.gov registration number NCT01440751.Registered 9/14/11Electronic supplementary materialThe online version of this article (doi:10.1186/s12886-016-0393-z) contains supplementary material, which is available to authorized users.

Phacotrabeculectomy using collagen matrix implant (Ologen®) versus mitomycin C: a prospective randomized controlled trial

“…() and Tanna et al. () reported more frequently, yet not significantly, early bleb leakages in OLO eyes. The possible reason can be the presence of the OLO implant over the scleral flap and elevation of the conjunctiva.…”

“…; Tanna et al. ). This is likely to be attributed to proper conjunctival growth over the filtering bleb when OLO implant is positioned over the scleral flap.…”

“…Tanna et al. () suggested that the thickness of the implant may be important, believing that the thicker disc may result in formation of excessive fibrotic tissue overlying the scleral flap and may result in insufficient egress of aqueous. In our study, we used the new version of the implant (model no.…”

Comparison between Ologen implant and Mitomycin C in trabeculectomy: A Systematic Review and Meta-Analysis

“…Most studies were excluded because they didn't compare the effect of Ologen implant and MMC or they were not prospective studies. After assessing the full text of the potentially 30 relevant articles, 15 RCTs were enligible for our inclusion criteria and finally to be included in this meta-analysis [22,[25][26][27][28][29][30][31][34][35][36][37][38][39][40] . The exclusion reasons were as follow: one was from the same patient group, and one compared the outcomes of trabeculectomy with or without an Ologen implant, seven were not comparative studies, five compared phacotrabeculectomy with Ologen implant and MMC, one was about secondary glaucomas trabeculectomy with following failed trabeculectomy with MMC.…”

Applying Hazardous Drug Standards to Antineoplastics Used for Ophthalmology Surgery

“…The antineoplastic medications fluorouracil and mitomycin C (MMC) are commonly used in the OR to treat ocular surface squamous neoplasia, and to suppress pathogenesis and fibrosis for ophthalmology procedures such as dacryocystorhinostomy and pterygium removal . Mitomycin C in particular is widely used intraoperatively to maintain optimal intraocular pressure after glaucoma surgery and to reduce postoperative scarring and inhibit fibroblasts …”