Dataset Information

Mitomycin-C Application Before versus After Scleral Flap Dissection in Trabeculectomy; a Randomized Clinical Trial.

ABSTRACT: PURPOSE:To compare trabeculectomy with mitomycin-C (MMC) application before versus after scleral flap dissection in terms of corneal endothelial cell loss and surgical outcomes. METHODS:In this double blind clinical trial, patients were randomized to MMC 0.02% application before (group A) or after (group B) scleral flap dissection. The main outcome measure was corneal endothelial cell density; secondary outcome measures included IOP, glaucoma medications, success rates (IOP ?21 and ?18 mmHg, defined as criterion 1 and 2, respectively) and complications. RESULTS:Overall, 99 eyes of 99 subjects including 72 male and 27 female subjects were operated and followed for at least 6 months. The study groups were comparable in terms of baseline variables. Outcomes of surgery were similar at six months in terms of IOP (11.8±5.8 vs. 11.7±5.5 mmHg, P=0.88) and number of medications (0.2 ±0.6 vs 0.1±0.4, P=0.45). Overall success was comparable at months 1 and 3, but higher in group B at month 6 (82.0% vs. 63.3%, P=0.036 for criterion 1 and 78.9% vs. 59.2%, P=0.044 for criterion 2). Hypotony was more prevalent in group B (8.0% versus 2.0%) but the difference was not significant (P=0.38). Endothelial cell density loss (2.2±7.3 vs 0.9±6.3%, P=0.567) was comparable between the study groups. CONCLUSION:Corneal endothelial loss following trabeculectomy was comparable with MMC application before and after scleral flap dissection. The sequences were comparable in terms of postoperative IOP and glaucoma medications. Overall success rate was higher at six months in group B and the rate of hypotony was also higher, although insignificantly.

SUBMITTER: Yazdani S

PROVIDER: S-EPMC4795388 | biostudies-literature | 2015 Oct-Dec

REPOSITORIES: biostudies-literature

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Mitomycin-C Application Before versus After Scleral Flap Dissection in Trabeculectomy; a Randomized Clinical Trial.

Yazdani Shahin S Rezai Saeed S Pakravan Mohammad M Afrouzifar Mohsen M Ghahari Elham E

Journal of ophthalmic & vision research 20151001 4

<h4>Purpose</h4>To compare trabeculectomy with mitomycin-C (MMC) application before versus after scleral flap dissection in terms of corneal endothelial cell loss and surgical outcomes.<h4>Methods</h4>In this double blind clinical trial, patients were randomized to MMC 0.02% application before (group A) or after (group B) scleral flap dissection. The main outcome measure was corneal endothelial cell density; secondary outcome measures included IOP, glaucoma medications, success rates (IOP ≤21 an ...[more]

PMID: 27051483

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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.

Project description:This unicentric randomized clinical trial was designed to compare the surgical outcomes of mitomycin C-enhanced trabeculectomy (MMC-TRAB) with and without subtenon triamcinolone acetonide (TAAC) injection in patients with non-inflammatory glaucomas. This trial is registered at the Brazilian Registry of Clinical Trials (ReBEC) under the register number RBR-53f8nh. Consecutive non-inflammatory glaucoma patients requiring surgical intervention were randomized into two groups. In the control group, eyes underwent standard MMC-TRAB, while in the intervention group, besides the standard MMC-TRAB, these eyes also received a subtenon TAAC injection (4mg) close to the bleb site at the end of the surgery. The main outcomes of the study were surgical success rates, intraocular pressure (IOP) and number of medications at all timepoints. Success was defined as IOP ≤ 15 mmHg and subdivided in complete or qualified according to the need of medication. A total of 75 eyes of 63 different patients were included (intervention group = 39 eyes; control group = 36 eyes). There was no difference between groups at baseline (p>0.11). Multivariable regression analysis indicated that IOP levels were significantly lower in the intervention group at 18 and 24 months of follow-up when number of medications was considered as a covariate (P<0.001). Complete success rates were higher in the intervention group at 06 (90.9% vs 68.7%; p = 0.03), 12 (87.2% vs 66.7%; p = 0.02) and 18 months (87.2% vs 66.7%; p = 0.02). Additionally, although success rates at 24 months were higher in the intervention group (82.0% vs 66.7%; p = 0.09), this difference did not reach statistical significance. Qualified success rates did not significantly differ between groups at all timepoints. In conclusion, this study found significantly lower IOPs levels at 18 and 24 months of follow-up and higher complete success rates until 18 months of follow-up, with the use of subtenon TAAC as an adjuvant to standard MMC-TRABs in non-inflammatory glaucoma patients.

Dataset Information

Mitomycin-C Application Before versus After Scleral Flap Dissection in Trabeculectomy; a Randomized Clinical Trial.

Publications

Mitomycin-C Application Before versus After Scleral Flap Dissection in Trabeculectomy; a Randomized Clinical Trial.

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