改良缝线辅助小梁切开术治疗亚洲原发性开角型青光眼：一项为期12个月随访的前瞻性研究
Modified suture-assisted canaloplasty in Asians with primary open-angle glaucoma: a prospective study with 12-month follow-up.
作者信息
Liang Ya, Yu Qiuli, Sun Hong, Gu Liuwei, Yuan Zhilan
机构信息
Department of Ophthalmology, the First Affiliated Hospital of Nanjing Medical University, No. 300 Guangzhou Road, Nanjing, 210029, China.
Department of Ophthalmology, the Second Affiliated Hospital of Nanjing Medical University, No.262 North Zhongshan Road, Nanjing, 210003, China.
出版信息
BMC Ophthalmol. 2022 May 4;22(1):202. doi: 10.1186/s12886-022-02424-9.
BACKGROUND
To evaluate the efficacy and safety of modified suture-assisted canaloplasty in Asians with primary open-angle glaucoma (POAG).
METHODS
A prospective, consecutive cases study, evaluating a modified canaloplasty by twisted 6/0 suture was performed on Asian POAG patients. Three modifications of this canaloplasty included opening the Schlemm's canal by viscocanalostomy, circumferential probing by a twisted 6/0 suture and loose suture of the superficial scleral flap. The twisted 6/0 suture was selected as a prober based on characteristical analysis of size and contact measurement as well as chemical composition conducted among 5/0, twisted 6/0 polypropylene sutures and the microcatheter. Success criteria were defined as intraocular pressure (IOP) ≤ 21 mmHg, 18 mmHg, 15 mmHg, and ≥ 20% reduction without (complete success) or with medications (qualified success). Efficacy was assessed by the success rate of circumferential catheterization, IOP values, the success rate of the surgery, the number of IOP-lowering medications, best-corrected vision acuity (BCVA), cup-to-disc ratio (C/D), and mean deviation (MD). Safety was evaluated by adverse events.
RESULTS
Forty eyes from 40 consecutive patients were included with a mean follow-up of 14.8 ± 3.0 months. Circumferential catheterization was successfully conducted in 36 eyes (90%). Mean IOP decreased from 26.2 ± 6.9 mmHg to 14.5 ± 2.7 mmHg at 12 months postoperatively. While medication numbers were reduced from 3.2 ± 0.6 to 0.5 ± 0.8 at month 12 (both p < 0.001). Qualified success rate was 97.2% [95% confidence interval (CI) 0.92-1.03], 86.1% (95% CI 0.74-0.98) and 66.7% (95% CI 0.51-0.83) at 12 months with three criteria. BCVA, C/D and MD did not show progression at 1-year follow-up (p > 0.05). Age, baseline IOP, and spherical equivalent negatively influenced the success rate significantly (all p < 0.05). Adverse events included hyphema (30.6%), IOP spike > 25 mmHg (8.3%), and peripheral synechia to the trabecular-Descemet's membrane (2.7%).
CONCLUSION
Twisted 6/0 suture can be an ideal material for cannulation. Modified suture-assisted canaloplasty is an effective, safe alternative with a cost-efficient feature for patients with POAG, especially in developing countries.
TRIAL REGISTRATION
This trial was registered in the Chinese Clinical Trial Registry ( ChiCTR1900028618 , 29/12/2019).
背景
评估改良缝线辅助小梁切开术治疗亚洲原发性开角型青光眼（POAG）患者的疗效和安全性。
方法
对亚洲POAG患者进行一项前瞻性、连续病例研究，评估通过6/0扭曲缝线进行的改良小梁切开术。该小梁切开术的三项改良包括通过粘小管切开术打开施莱姆管、用6/0扭曲缝线进行圆周探查以及浅层巩膜瓣的宽松缝合。基于对5/0、6/0扭曲聚丙烯缝线和微导管的尺寸、接触测量以及化学成分的特征分析，选择6/0扭曲缝线作为探子。成功标准定义为眼压（IOP）≤21 mmHg、18 mmHg、15 mmHg，且在不使用（完全成功）或使用药物（合格成功）的情况下降低≥20%。通过圆周置管成功率、IOP值、手术成功率、降低IOP的药物数量、最佳矫正视力（BCVA）、杯盘比（C/D）和平均偏差（MD）评估疗效。通过不良事件评估安全性。
结果
连续40例患者的40只眼纳入研究，平均随访14.8±3.0个月。36只眼（90%）成功进行了圆周置管。术后12个月时，平均IOP从26.2±6.9 mmHg降至14.5±2.7 mmHg。12个月时药物数量从3.2±0.6减少至0.5±0.8（均p<0.001）。三项标准下12个月时的合格成功率分别为97.2%[95%置信区间（CI）0.92 - 1.03]、86.1%（95%CI 0.74 - 0.98）和66.7%（95%CI 0.51 - 0.83）。1年随访时BCVA、C/D和MD未显示进展（p>0.05）。年龄、基线IOP和等效球镜度数对成功率有显著负面影响（均p<0.05）。不良事件包括前房积血（30.6%）、IOP峰值>25 mmHg（8.3%）和小梁-Descemet膜周边粘连（2.7%）。
结论
6/0扭曲缝线可成为置管的理想材料。改良缝线辅助小梁切开术对POAG患者是一种有效、安全且具有成本效益的替代方法，尤其在发展中国家。
试验注册
本试验在中国临床试验注册中心注册（ChiCTR1900028618，2019年12月29日）。
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