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临床试验/NCT04726267
NCT04726267Unknown不适用

Incidence of Complete Posterior Vitreous Detachment After Trabeculectomy.

Khon Kaen University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
46
试验地点
2
主要终点
Incidence of PVD

研究概览

简要总结

Intraocular surgery could induce vitreous degeneration and posterior vitreous detachment (PVD). Vitreomacular interface (VMI) abnormalities usually are caused by abnormal PVD, vitreoschisis and partial-thickness PVD. Furthermore, the PVD could induce the peripheral break. The incidence of peripheral break and epimacular membrane (EMM) after pneumatic retinopexy were 11.7% and 4-11%, respectively. Although multiple intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections induced PVD of 5.6%, but peripheral break was reported as only 0.67%.

The most common intraocular surgery is cataract surgery. From the literature review, many methods were used to detect the PVD after phacoemulsification. The former studies used indirect ophthalmoscopy and ocular ultrasound for diagnosis of PVD. The later studies used the optical coherence tomography (OCT) for PVD detection. The OCT device had higher effectiveness in evaluation of the posterior segment, then it can detect post-phacoemulsification PVD more and early than previous studies. Ivastinovic et al demonstrated 59.2% of patients had PVD at 1 month after phacoemulsification, and increased up to 71.4% at 3 months. The incidence of rhegmatogenous retinal detachment (RRD) after phacoemulsification is gradually increased with time. The accumulative risk of RRD was increased from 0.27% at 1 year to 1.27% at 20 years after phacoemulsification.

详细描述

Trabeculectomy is one of the intraocular surgery. Although the volume of intraocular fluid use during the trabeculectomy was much less than used during phacoemulsification, trabeculectomy also could induce the PVD and it's sequelae such as VMI abnormalities. Because the baseline visual acuity of glaucoma patients who were indicated for trabeculectomy usually quite poor, so the sequelae of PVD can cause more visual loss. The incidence of PVD after trabeculectomy has never been published before and nowadays no standard guideline for retinal examination or screening after surgery. Furthermore, Tsukahara et al introduced wide-field OCT-based PVD classification. The new OCT device with higher technology will be useful in PVD detection.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary open angle glaucoma or primary angle closure glaucoma
  • Age 18-65 years
  • Could be taken the wide-field OCT images
  • Written informed consent

排除标准

  • History of intraocular inflammation or infection
  • History of ocular trauma or head trauma
  • History of intraocular surgery such as intravitreal drug injection and cataract surgery
  • History of vitreoretinal diseases such as diabetic retinopathy, retinal vascular occlusion and age-related macular degeneration
  • History of laser treatment including laser capsulotomy and retinal photocoagulation
  • High myopia; spherical equivalence >4 diopters
  • Complete PVD was detected before the enrollment

结局指标

主要结局

Incidence of PVD

时间窗: 12 months

complete PVD

次要结局

  • The incidence of VMI abnormalities(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suthasinee Sinawat

KKU Eye Center, Department of Ophthalmology

Khon Kaen University

研究点 (2)

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