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Efficacy and Safety of Ologen Implant Versus Mitomycin C in Primary Trabeculectomy: A Meta-analysis of Randomized Clinical Trials.

Authors » Ji Q , Qi B , Liu L , Guo X , Zhong J

Journal » Journal of glaucoma

Year » 2015

Links » Pubmed DOI

This article includes 6 Primary studies 6 Primary studies (6 references)

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PURPOSE:: To assess the efficacy and safety of trabeculectomy with Ologen implant versus trabeculectomy with mitomycin C (MMC) for treatment of glaucoma. PATIENTS AND METHODS:: Medline, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials, and Google Scholar were searched for relevant randomized controlled trials. The outcome measures of efficacy were intraocular pressure and glaucoma medications reductions, and success rate. Safety estimates were measured by relative ratio for complications. RESULTS:: A total of 6 studies including 224 participants were included in this meta-analysis. Ologen implant was associated with a numerically lower but nonsignificant percentage reduction in IOP compared with MMC. The pooled absolute IOP decreases from baseline (95% confidence interval) were: 13.28 mm Hg (11.33-15.23 mm Hg) versus 15.8 mm Hg (13.21-18.38 mm Hg) at 1 month; 12.95 mm Hg (11.45-14.44 mm Hg) versus 13.87 mm Hg (11.77-15.97 mm Hg) at 3 months; 11.44 mm Hg (8.77-14.11 mm Hg) versus 13.34 mm Hg (11.48-15.20 mm Hg) at 6 months; 10.05 mm Hg (7.14-12.96 mm Hg) versus 11.59 mm Hg (10.27-12.91 mm Hg) at 12 months; and 12.17 mm Hg (8.88-15.47 mm Hg) versus 10.64 mm Hg (8.15-13.12 mm Hg) at 24 months for Ologen implant versus MMC, respectively. There was no significant difference in the reduction in glaucoma medications, success rate, and incidence of complications. CONCLUSIONS:: Trabeculectomy with an Ologen implant is comparable to the use of MMC with a similar long-term success rate. However, it does not seem to offer significant advantages of avoiding the potential complications related to MMC.

Ologen implant versus mitomycin C for trabeculectomy: A systematic review and meta-analysis

Authors » He M , Wang W , Zhang X , Huang W

Journal » PloS one

Year » 2014

Links » Pubmed DOI PubMed Central

This article includes 7 Primary studies 7 Primary studies (7 references)

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Objective: To 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. Methods: A 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. Results: Seven 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. Conclusions: The 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. © 2014 He et al.

PURPOSE:

: To assess the efficacy and safety of trabeculectomy with Ologen implant versus trabeculectomy with mitomycin C (MMC) for treatment of glaucoma.

PATIENTS AND METHODS:

: Medline, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials, and Google Scholar were searched for relevant randomized controlled trials. The outcome measures of efficacy were intraocular pressure and glaucoma medications reductions, and success rate. Safety estimates were measured by relative ratio for complications.

RESULTS:

: A total of 6 studies including 224 participants were included in this meta-analysis. Ologen implant was associated with a numerically lower but nonsignificant percentage reduction in IOP compared with MMC. The pooled absolute IOP decreases from baseline (95% confidence interval) were: 13.28 mm Hg (11.33-15.23 mm Hg) versus 15.8 mm Hg (13.21-18.38 mm Hg) at 1 month; 12.95 mm Hg (11.45-14.44 mm Hg) versus 13.87 mm Hg (11.77-15.97 mm Hg) at 3 months; 11.44 mm Hg (8.77-14.11 mm Hg) versus 13.34 mm Hg (11.48-15.20 mm Hg) at 6 months; 10.05 mm Hg (7.14-12.96 mm Hg) versus 11.59 mm Hg (10.27-12.91 mm Hg) at 12 months; and 12.17 mm Hg (8.88-15.47 mm Hg) versus 10.64 mm Hg (8.15-13.12 mm Hg) at 24 months for Ologen implant versus MMC, respectively. There was no significant difference in the reduction in glaucoma medications, success rate, and incidence of complications.

CONCLUSIONS:

: Trabeculectomy with an Ologen implant is comparable to the use of MMC with a similar long-term success rate. However, it does not seem to offer significant advantages of avoiding the potential complications related to MMC.

Systematic Review Question » Systematic review of interventions

Systematic reviews including this primary study