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Preserflo微分流器在不同类型青光眼患者中的安全性和有效性

Safety and Efficacy of Preserflo Microshunt in Different Subtypes of Glaucoma.

作者信息

Al Habash Ahmed, Alshaibani Askar K

机构信息

Department of Ophthalmology, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman bin Faisal University, Dammam, Saudi Arabia.

Department of Ophthalmology, Dhahran Eye Specialist Hospital, Dhahran, Saudi Arabia.

出版信息

Clin Ophthalmol. 2025 Sep 4;19:3215-3226. doi: 10.2147/OPTH.S551700. eCollection 2025.

Abstract

BACKGROUND

Glaucoma is the leading cause of blindness worldwide. Intraocular pressure is considered the only modifiable risk factor; different modalities have been developed to target this risk factor. Trabeculectomy, a gold standard glaucoma surgery, carries high complication rate, as a result alternative different modalities were developed to mitigate this risk. A newly developed device, Preserflo Microshunt, aims to decrease the complication rate of trabeculectomy with similar efficacy. In this study, we assessed the safety and efficacy of the device in Saudi Arabia, where the patient population has a darker skin color with more intense scarring and a hot climate that can exacerbate ocular surface dryness and compromise conjunctival health.

PURPOSE

This retrospective study aims to assess the safety and efficacy of Preserflo Microshunt with Mitomycin C 0.5 mg/mL in managing different subtypes of glaucoma.

METHODS

Retrospective, interventional single-arm study.

RESULTS

This study included 45 eyes from 45 patients. It included 33 (73.3%) males and 12 (26.7%) females. A median age of 56 years (Interquartile Range 39-63, range 20-77). The Preserflo Microshunt with Mitomycin C 0.5 mg/mL achieved a complete success rate 83.3% at 6 months follow-up and of 80% at 1 year. A significant reduction in both the number of anti-glaucoma medications and intraocular pressure at 1 month, 3 months, 6 months, and 1 year post-operatively was observed (P<0.001 for all). The most common early-onset complication was transient hypotony, observed in 12 eyes (26.7%), and the most common late-onset complication was cataract progression, which was observed in 5 (16.67%) patients at 1 year.

CONCLUSION

Preserflo Microshunt is a viable option for glaucoma patients showing excellent success and low complication rates with good safety profile.

摘要

背景

青光眼是全球失明的主要原因。眼压被认为是唯一可改变的风险因素;已开发出不同方法来针对这一风险因素。小梁切除术作为青光眼手术的金标准,并发症发生率较高,因此开发了不同的替代方法来降低这种风险。一种新开发的装置Preserflo Microshunt旨在降低小梁切除术的并发症发生率,同时具有相似的疗效。在本研究中,我们评估了该装置在沙特阿拉伯的安全性和有效性,该国患者肤色较深,瘢痕形成更严重,且气候炎热,可能会加剧眼表干燥并损害结膜健康。

目的

本回顾性研究旨在评估含0.5 mg/mL丝裂霉素C的Preserflo Microshunt治疗不同亚型青光眼的安全性和有效性。

方法

回顾性、介入性单臂研究。

结果

本研究纳入了45例患者的45只眼。其中男性33例(73.3%),女性12例(26.7%)。中位年龄为56岁(四分位间距39 - 63岁,范围20 - 77岁)。含0.5 mg/mL丝裂霉素C的Preserflo Microshunt在6个月随访时的完全成功率为83.3%,1年时为80%。术后1个月、3个月、6个月和1年时,抗青光眼药物数量和眼压均显著降低(所有P<0.001)。最常见的早期并发症是短暂性低眼压,见于12只眼(26.7%),最常见的晚期并发症是白内障进展,1年时在5例(16.67%)患者中观察到。

结论

Preserflo Microshunt对于青光眼患者是一种可行的选择,成功率高、并发症发生率低且安全性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c94/12417707/05e9e9444dcb/OPTH-19-3215-g0001.jpg

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