Canaloplasty: Circumferential viscodilation and tensioning of Schlemm canal using a flexible microcatheter for the treatment of open-angle glaucoma in adults Two-year interim clinical study results

Canaloplasty: Circumferential viscodilation and tensioning of Schlemm canal using a flexible microcatheter for the treatment of open-angle glaucoma in adults Two-year interim clinical study results
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DOI:
10.1016/j.jcrs.2009.01.010
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发表时间:
2009-05-01
影响因子:
2.8
通讯作者:
Samuelson, Thomas W.
Samuelson, Thomas W.
中科院分区:
医学2区
文献类型:
--
作者:
Lewis, Richard A.;von Wolff, Kurt;Samuelson, Thomas W.

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目得:评价术后2年的安全性和有效性canaloplasty(周向粘性扩张和紧张的Schlemm管内壁)治疗开角型青光眼(OAG)。设置:多中心surgical sites.METHODS:这项国际前瞻性研究包括成人OAG患者青光眼手术或联合青光眼-白内障手术。合格的术前眼内压(IOP)至少为16 mm Hg,历史IOP至少为21 mm Hg。对髓腔的整个圆周进行粘性扩张,并使用微导管放置小梁张紧缝线。结果:在24个月时,所有127只眼睛(1127名患者)的平均IOP为16.0 mm Hg +/- 4.2(SD),平均青光眼药物使用为0.5 +/- 0.8(基线值为23.6 +/- 4.8 mm Hg和1.9 +/- 0.8药物)。仅行泪小管成形术的眼睛的平均IOP为16.3 ± 3.7 mm Hg和0.6 ± 0.8药物(基线值为23.2 ± 4.0 mm Hg和2.0 ± 0.8药物)。接受青光眼-白内障联合手术的患眼的平均IOP为13.4 ± 4.0 mm Hg和0.2 ± 0.4药物(基线值为23.1 ± 5.5 mm Hg和1.7 ± 1.0药物)。所有时间点的眼压和药物使用结果与基线相比均具有统计学意义(P
PURPOSE: To evaluate 2-year postsurgical safety and efficacy of canaloplasty (circumferential viscodilation and tensioning of the inner wall of Schlemm canal) to treat open-angle glaucoma (OAG).SETTING: Multicenter surgical sites.METHODS: This international prospective study comprised adult OAG patients having glaucoma surgery or combined glaucoma-cataract surgery. Qualifying preoperative intraocular pressure (IOP) was at least 16 mm Hg and historical IOP, at least 21 mm Hg. The full circumference of the canal was viscodilated and a trabecular tensioning suture placed with a microcatheter. Primary outcome measures included IOP and glaucoma medication use.RESULTS: At 24 months, all 127 eyes (1127 patients) had a mean IOP of 16.0 mm Hg +/- 4.2 (SD) and mean glaucoma medication use of 0.5 +/- 0.8 (baseline values 23.6 +/- 4.8 mm Hg and 1.9 +/- 0.8 medications). Eyes with canaloplasty alone had a mean IOP of 16.3 +/- 3.7 mm Hg and 0.6 +/- 0.8 medications (baseline values 23.2 +/- 4.0 mm Hg and 2.0 +/- 0.8 medications). Eyes with combined glaucoma-cataract surgery had a mean IOP of 13.4 +/- 4.0 mm Hg and 0.2 +/- 0.4 medications (baseline values 23.1 +/- 5.5 mm Hg and 1.7 +/- 1.0 medications). The IOP and medication use results at all time points were statistically significant versus baseline (P