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.
Highlights
Antifibrotic agents are commonly utilized to enhance the success rates of trabeculectomy
We report the results of a multicenter randomized clinical trial designed to compare efficacy and safety of trabeculectomy or combined phacoemulsification and trabeculectomy with MMC versus Collagen Matrix (CM)
Four declined to participate and a decision was made to cancel the plan for trabeculectomy in one subject due to improved intraocular pressure (IOP)
Summary
Antifibrotic agents are commonly utilized to enhance the success rates of trabeculectomy. 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). Antifibrotic therapy with mitomycin-C (MMC) or 5-fluorouracil (5-FU) is a valuable adjunct to trabeculectomy for reducing scarring and improving IOP-lowering efficacy. Chen et al [8] further advanced the concept of using a porous collagen matrix (CM) implant as an adjunct to trabeculectomy. Their approach was to use the implant to resist over-filtration in the early post-operative period by acting as a physical barrier and to maintain long-term pressure control by promoting the development of a loosely organized scar as the implant degrades. Eyes undergoing trabeculectomy with CM implantation maintained IOP reduction to 55% below baseline at day 28, whereas control eyes undergoing trabeculectomy without CM reverted to baseline IOP levels by day 21 [8]
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