Dataset Information

Efficacy of Adjunctive Subconjunctival Bevacizumab on the Outcomes of Primary Trabeculectomy With Mitomycin C: A Prospective Randomized Placebo-controlled Trial.

ABSTRACT: PURPOSE:To evaluate the efficacy of subconjunctival bevacizumab (ScB) as adjuvant therapy to primary trabeculectomy with mitomycin C (MMC) in primary open-angle glaucoma. MATERIALS AND METHODS:Forty-six eyes of primary open-angle glaucoma patients were randomized to receive ScB (1.25 mg/0.05 mL) injections (the MMC+ScB group) at the end of the operations, or sham-treated controls (the MMC group). Intraocular pressure (IOP) was the primary outcome and secondary outcomes included bleb appearance, visual acuity, number of medications, complications, and proportion of eyes achieving successful outcomes at the 12-month follow-up. RESULTS:Of 39 eyes, 20 eyes from the MMC+ScB group, and 19 eyes from the MMC group completed the follow-up. The mean postoperative IOP was 15.5±4.1 mm Hg in the MMC+ScB group (P<0.01; 40% reduction), and 14.7±4.3 mm Hg in the MMC group (P<0.01; 44% reduction). The differences in IOPs, at all follow-up visits, were not significant (P>0.05). The mean bleb vascularity score, at 1 month, in the MMC+ScB group was lower than the MMC group (1.55±0.51 vs. 2.26±0.6, respectively, P=0.01), but was not retained at follow-ups. The success rates at 12 months after surgery were 85% in the MMC+ScB group and 89.5% in the MMC group (P=0.53). The cumulative probabilities of surgical success were 80% and 73.7% in the MMC+ScB and in the MMC group, respectively (P=0.52). CONCLUSION:Single adjunctive ScB injection did not appear to have an additive benefit on outcomes of MMC trabeculectomy, in terms of IOPs and success rates.

SUBMITTER: Kiddee W

PROVIDER: S-EPMC4614532 | biostudies-literature | 2015 Oct-Nov

REPOSITORIES: biostudies-literature

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Efficacy of Adjunctive Subconjunctival Bevacizumab on the Outcomes of Primary Trabeculectomy With Mitomycin C: A Prospective Randomized Placebo-controlled Trial.

Kiddee Weerawat W Orapiriyakul Lachaya L Kittigoonpaisan Kaneungnit K Tantisarasart Thawat T Wangsupadilok Boonchai B

Journal of glaucoma 20151001 8

<h4>Purpose</h4>To evaluate the efficacy of subconjunctival bevacizumab (ScB) as adjuvant therapy to primary trabeculectomy with mitomycin C (MMC) in primary open-angle glaucoma.<h4>Materials and methods</h4>Forty-six eyes of primary open-angle glaucoma patients were randomized to receive ScB (1.25 mg/0.05 mL) injections (the MMC+ScB group) at the end of the operations, or sham-treated controls (the MMC group). Intraocular pressure (IOP) was the primary outcome and secondary outcomes included bl ...[more]

PMID: 25393038

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Project description:Antifibrotic 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).A 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.The 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).Use 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.ClinicalTrials.gov registration number NCT01440751 . Registered 9/14/11.

Dataset Information

Efficacy of Adjunctive Subconjunctival Bevacizumab on the Outcomes of Primary Trabeculectomy With Mitomycin C: A Prospective Randomized Placebo-controlled Trial.

Publications

Efficacy of Adjunctive Subconjunctival Bevacizumab on the Outcomes of Primary Trabeculectomy With Mitomycin C: A Prospective Randomized Placebo-controlled Trial.

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