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Randomised clinical trial for morphological changes of trabecular meshwork between Kahook dual-blade goniotomy and ab interno trabeculotomy with a microhook
Scientific Reports ( IF 3.8 ) Pub Date : 2023-11-27 , DOI: 10.1038/s41598-023-48121-5
Shogo Arimura 1 , Kentaro Iwasaki 1 , Yusuke Orii 1 , Ryohei Komori 1 , Yoshihiro Takamura 1 , Masaru Inatani 1
Affiliation  

We demonstrated whether the difference of trabecular meshwork remodeling occur depending on the incisional cross-sectional area by comparing Kahook dual-blade goniotomy (KDB) and ab interno trabeculotomy with a microhook. Phakic eyes with primary open-angle or exfoliative glaucoma were randomised into a KDB or a microhook group. The primary outcome was an incisional cross-sectional area quantified by anterior segment optical coherence tomography. In subgroup analysis, the number of patients with the unidentifiable incisional area was compared between the groups. Secondary outcomes were the rate of intraocular pressure changes, the laser flare metre values, corneal endothelial cell densities, the number of glaucoma medications, the usage rate per glaucoma medication type and postoperative complications between the two groups. A total of 29 eyes in 29 patients in the KDB and microhook group were included respectively, with an overall mean age of 72.6 ± 8.1 years. The incisional cross-sectional area of the KDB group was significantly larger at 1 week and at 1, 6 and 12 months (p < 0.01) postoperatively. The number of patients with the nonidentified incisional area was higher at 1, 6 and 12 months postoperatively (p ≤ 0.03) in the microhook group. The flare values in the KDB group were higher than those in the microhook group at 12 months postoperatively (p = 0.02). No significant differences were observed in other secondary outcomes. Incisional cross-sectional area remains larger in eyes treated with KDB goniotomy than in those treated with ab interno trabeculotomy with the microhook, whereas KDB goniotomy did not have an advantage in controlling intraocular pressure postoperatively.

Trial registration: UMIN000041290 (UMIN, University Hospital Medical Information Network Clinical Trials Registry of Japan; date of access and registration, 03/08/2020).



中文翻译:


Kahook 双刀片前房角切开术与微钩经内小梁切开术之间小梁网形态变化的随机临床试验



我们通过比较 Kahook 双刀片前房角切开术 (KDB) 和使用微钩的腹内小梁切开术,证明了小梁网重塑的差异是否会根据切口横截面积而发生。患有原发性开角型或剥脱性青光眼的有晶状体眼被随机分为 KDB 组或微钩组。主要结果是通过眼前段光学相干断层扫描量化的切口横截面积。在亚组分析中,比较各组之间切口区域无法识别的患者数量。次要结果是两组之间的眼压变化率、激光耀斑仪值、角膜内皮细胞密度、青光眼药物数量、每种青光眼药物类型的使用率以及术后并发症。 KDB 组和 microhook 组分别纳入 29 名患者的 29 只眼,总体平均年龄为 72.6 ± 8.1 岁。 KDB组的切口横截面积在术后1周以及1、6和12个月时明显更大( p <0.01)。微钩组术后 1、6 和 12 个月时切口区域未识别的患者数量较多 ( p ≤ 0.03)。术后 12 个月,KDB 组的耀斑值高于微钩组 ( p = 0.02)。其他次要结局没有观察到显着差异。 KDB 前房角切开术治疗的眼睛切口横截面积仍然大于采用微钩经内小梁切开术治疗的眼睛,而 KDB 前房角切开术在控制术后眼压方面没有优势。


试验注册: UMIN000041290(UMIN,日本大学医院医疗信息网络临床试验注册中心;访问和注册日期,2020 年 3 月 8 日)。

更新日期:2023-11-28
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