Ali Mostafaei1, Nazli Taheri2, Morteza Ghojazadeh1, Atena Latifi3, Neda Moghaddam3. 1. Iran Evidence-Based Medicine Research Center (EBM), Tabriz University of Medical Sciences, Tabriz, Iran. 2. Nikookari Eye Hospital, Tabriz University of Medical Sciences, Tabriz, 5154645395, Iran. nazli.taheri81@yahoo.com. 3. Nikookari Eye Hospital, Tabriz University of Medical Sciences, Tabriz, 5154645395, Iran.
Abstract
PURPOSE: Comparison of the effect of mitomycin C (MMC) versus bevacizumab-methylcellulose mixture (BMM) on combined phacoemulsification and non-penetrating deep sclerectomy surgery on the intraocular pressure in patients with open-angle glaucoma was made. METHODS: The current study is a controlled, randomized, double-blind clinical trial. Thirty-eight patients were enrolled, with a total of 40 eyes, and underwent acombined phacoemulsification and non-penetrating deep sclerectomy surgery from 2016 to 2017. MMC with concentration of 0.2 mg/mL for 2 min was used for 20 eyes before separating the scleral flap, and 0.3 mL of BMM (bevacizumab 1.25 mg incorporated into 2% methylcellulose) was injected subconjunctivally following surgery. The success rate of surgery was categorized as complete, relative and failure. Fisher's exact, Mann-Whitney U and Chi-square tests were employed to data analysis. A p value < 0.05 was supposed significant. RESULTS: Patients had the same distribution in terms of age, sex, type of glaucoma and type of cataract. Patients were followed up for a mean of 6 months. The mean intraocular pressure before surgery in the MMC group was 24.85 ± 2.83 mmHg with 3.2 ± 0.523 anti-glaucoma drugs, which reached 13.75 ± 3.552 mmHg with 0.15 ± 0.489 anti-glaucoma drugs at the latest visit. The average intraocular pressure before surgery in the BMM group was 24.45 ± 2.48 mmHg with 2.9 ± 0.641 anti-glaucoma drugs, which reached 15.40 ± 3.267 mmHg with 0.25 ± 0.55 anti-glaucoma drug at the last follow-up. The intraocular pressure was notably lower in the MMC group than BMM group 6 months after surgery. There was not a significant difference from the aspect of success rate and failure rate among the two groups at the 6-month follow-up (p = 0.135). DISCUSSION: Based on the results of this study, MMC and bevacizumab-methylcellulose both seem to be effective in the success of combined phacoemulsification and non-penetrating deep sclerectomy surgery, but MMC decreases intraocular pressure in patients at 6 months post-surgery.
RCT Entities:
PURPOSE: Comparison of the effect of mitomycin C (MMC) versus bevacizumab-methylcellulose mixture (BMM) on combined phacoemulsification and non-penetrating deep sclerectomy surgery on the intraocular pressure in patients with open-angle glaucoma was made. METHODS: The current study is a controlled, randomized, double-blind clinical trial. Thirty-eight patients were enrolled, with a total of 40 eyes, and underwent a combined phacoemulsification and non-penetrating deep sclerectomy surgery from 2016 to 2017. MMC with concentration of 0.2 mg/mL for 2 min was used for 20 eyes before separating the scleral flap, and 0.3 mL of BMM (bevacizumab 1.25 mg incorporated into 2% methylcellulose) was injected subconjunctivally following surgery. The success rate of surgery was categorized as complete, relative and failure. Fisher's exact, Mann-Whitney U and Chi-square tests were employed to data analysis. A p value < 0.05 was supposed significant. RESULTS:Patients had the same distribution in terms of age, sex, type of glaucoma and type of cataract. Patients were followed up for a mean of 6 months. The mean intraocular pressure before surgery in the MMC group was 24.85 ± 2.83 mmHg with 3.2 ± 0.523 anti-glaucoma drugs, which reached 13.75 ± 3.552 mmHg with 0.15 ± 0.489 anti-glaucoma drugs at the latest visit. The average intraocular pressure before surgery in the BMM group was 24.45 ± 2.48 mmHg with 2.9 ± 0.641 anti-glaucoma drugs, which reached 15.40 ± 3.267 mmHg with 0.25 ± 0.55 anti-glaucoma drug at the last follow-up. The intraocular pressure was notably lower in the MMC group than BMM group 6 months after surgery. There was not a significant difference from the aspect of success rate and failure rate among the two groups at the 6-month follow-up (p = 0.135). DISCUSSION: Based on the results of this study, MMC and bevacizumab-methylcellulose both seem to be effective in the success of combined phacoemulsification and non-penetrating deep sclerectomy surgery, but MMC decreases intraocular pressure in patients at 6 months post-surgery.
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