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. 2020 Dec 26;10(1):59.
doi: 10.3390/jcm10010059.

Comparison of the Efficacy and Safety of Trabeculectomy with Mitomycin C According to Concentration: A Prospective Randomized Clinical Trial

Bo Ram Seol  1   2 , Sang Yoon Lee  1   3 , Yu Jeong Kim  4 , Young Kook Kim  1   4 , Jin Wook Jeoung  1   4 , Ki Ho Park  1   4
Affiliations

Comparison of the Efficacy and Safety of Trabeculectomy with Mitomycin C According to Concentration: A Prospective Randomized Clinical Trial

Bo Ram Seol et al. J Clin Med. .

Abstract

(1) Background: Mitomycin C (MMC) is commonly used during trabeculectomy. However, there is no consensus on which concentration should be used. We aimed to compare the efficacy and safety of 0.2 mg/mL and 0.4 mg/mL of MMC in eyes undergoing trabeculectomy. (2) Methods: Thirty-six eyes (36 glaucoma patients) were randomized to undergo a trabeculectomy with 0.2 mg/mL or 0.4 mg/mL of MMC. The success rate was evaluated according to three criteria: (A) intraocular pressure (IOP) ≤18 mmHg and IOP reduction ≥20%; (B) IOP ≤15 mmHg and IOP reduction ≥25%; (C) IOP ≤12 mmHg and IOP reduction ≥30%. Cox's proportional hazard model was used to identify the predictive factors for failure. Immunohistochemical procedures for matrix metalloproteinase (MMP) were performed on Tenon's tissue. Bleb morphology was evaluated. Safety was assessed based on the incidence of complications. (3) Results: Of the 36 eyes, 19 underwent trabeculectomy with 0.2 mg/mL of MMC and 17 with 0.4 mg/mL. The success rates were 75%, 67%, and 47% at 6 months for criteria A, B, and C, respectively. There were no significant differences between the two groups. High MMP-9 staining and low preoperative IOP were associated with failure (hazard ratio (HR), 5.556; p = 0.033, and HR, 0.936; p = 0.033). Complications included hypotony in two eyes (6%), hyphema in one eye (3%), and choroidal detachment in one eye (3%). (4) Conclusions: Trabeculectomy with 0.2 mg/mL and 0.4 mg/mL of MMC showed similar IOP-control effects to those recorded in previous studies, along with a low rate of complications. There was no significant difference in efficacy or safety between the 0.2 mg/mL and 0.4 mg/mL MMC groups.

Keywords: efficacy; mitomycin C; safety; trabeculectomy.

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Conflict of interest statement

The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

Figures

Figure 1
Figure 1
Flow chart according to Consolidated Standards of Reporting Trials (CONSORT).
Figure 2
Figure 2
Kaplan–Meier estimates for surgical success according to three criteria for success. Criteria A (intraocular pressure (IOP) ≤ 18 mmHg and IOP reduction ≥ 20%), B (IOP ≤ 15 mmHg and IOP reduction ≥ 25%), C (IOP ≤ 12 mmHg and IOP reduction ≥ 30%).
See this image and copyright information in PMC

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