Ologen Implant versus Mitomycin C for Trabeculectomy: A Systematic Review and Meta-Analysis

Abstract

ObjectiveTo evaluate the application of the Ologen implant compared to mitomycin C (MMC) on the outcome of trabeculectomy and to examine the balance of risks and benefits.MethodsA systematic literature search (Pubmed, Embase, the Cochrane Library, and the Chinese Biomedicine Database) was performed. Randomized controlled trials comparing the Ologen implant with MMC in trabeculectomy were selected. The efficacy measures were the weighted mean differences (WMDs) for the intraocular pressure reduction (IOPR), the reduction in glaucoma medications, and the relative risks (RRs) for success rates. The tolerability measures were RRs for adverse events. The pooled effects were calculated using the random-effects model.ResultsSeven randomized controlled trials including 227 eyes were included in this meta-analysis. The WMDs of the IOPR comparing the Ologen group with the MMC group were −2.98 (95% Cl: −5.07 to −0.89) at one month, −1.41 (−3.72 to 0.91) at three months, −1.69 (−3.68 to 0.30) at six months, −1.94 (−3.88 to 0.01) at 12 months, and 0.65 (−2.17 to 0.47) at 24 months. There was no statistically significance except at one and 12 months after surgery. No significant difference in the reduction in glaucoma medications or complete and qualified success rates were found. The rates of adverse events also did not differ significantly between Ologen and MMC.ConclusionsThe Ologen implant is comparable with MMC for trabeculectomy in IOP-lowering efficacy, reduction in the number of glaucoma medications, success rates, and tolerability. However, the results should be interpreted cautiously since relevant evidence is still limited, although it is accumulating. Further large-scale, well-designed randomized controlled trials are urgently needed.

Ex-PRESS outcomes using mitomycin-C, Ologen alone, Ologen with 5-fluorouracil

“…The suboptimal performance of Ologen alone compared with MMC or Ologen with 5-FU is consistent with previous reports showing patients who receive MMC rather than Ologen have significantly lower IOP at 12 months [12][13][14]. This finding was also reinforced recently in a meta-analysis showing that patients undergoing trabeculectomy with MMC rather than Ologen experienced on average 1.94 mm Hg greater reduction in IOP, and that this difference was statistically significant [15]. Although there have been numerous studies that fail to show a difference, these studies have generally not been formally designed as non-inferiority trials and may have failed to show a difference due to lack of power [8][9][10].…”

“…A recent meta-analysis showed greater IOP reduction with MMC that was significant at 12 months follow-up, but noted the persistent scarcity of comparative studies with Ologen [15]. In addition, there is no study to compare the effectiveness of Ologen when it is combined with less potent but safer anti-fibrotic agent, such as 5-FU.…”

Device modified trabeculectomy for glaucoma

“…When metaanalysis of outcomes is appropriate, pooling across studies should increase the power and yield valuable information. Authors of a few recently published articles have addressed the effectiveness and safety of the Ex-PRESS and Ologen devices (Chen 2014;He 2014;Wang 2013a). However, a comprehensive, rigorous systematic review in this area is warranted.…”

Comparison of the Outcomes of Trabeculectomy with 5-Fluorouracil versus Ologen Implant in Primary Open-Angle Glaucoma

“…The results are, however, not completely consistent. Some studies [12][13][14][15][16][17][18] have found that the 2 procedures are comparable in lowering IOP whereas others have suggested that Ologen is inferior to MMC [19,20] . To the best of our knowledge, this is the first study to compare the outcomes of trabeculectomy with 5-FU versus Ologen implant in primary open-angle glaucoma.…”