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临床试验/NCT03970148
NCT03970148Unknown不适用

YAG Laser Vitreolysis of Symptomatic Vitreal Floaters

University Hospital of Split2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年4月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Number of patients with resolution of symptoms

研究概览

简要总结

Vitreous fluid, containing 95% water, fills the space behind the lens. Its gelatinous consistency is due to the presence of hyaluronic acid, mucopolysaccharide and collagen fibers. With age, the collagen aggregates into parallel bundles, bound by cross links, leaving the pockets of liquid in the glass body. This redistribution is referred to as syneresis, which is found in 90% older than 40 years. After liquefaction, the vitreous enters the retroviral space and separates the posterior hyaloid membrane from the retina. When separating from the optical disk it forms an annular formation (Weiss ring) in front of the optical disc. These agglomerated collagen bundles (opacities) disperse the photons of light and are perceived by the patients as a "gray silhouette-like artifact". Two major interventions for these symptoms include Nd: YAG laser vitreolysis and vitrectomy. The less invasive method Nd: YAG laser increases the temperature of the opacity thus vaporizing them to smaller fragments that are easier to sediment onto the bottom of the vitreous cavity thereby relieving the symptoms.

研究设计

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

入排标准

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

入选标准

  • Age 18 years or older
  • Is able to give written informed consent to the procedure
  • Patients with clinical symptoms of floaters and clinically confirmed diagnosis of opacity in the vitreous body.

排除标准

  • Inability to tolerate the procedure
  • Blurred anterior eye segment
  • Cataract or Intraocular lens opacity
  • Blurred posterior eye segment
  • Active eye inflammation
  • Iris synechiae
  • Uncontrolled intraocular pressure elevation
  • Peripheral retinal degeneration

研究组 & 干预措施

Nd: YAG laser treatment

Experimental

Before treatment an optical coherence tomography (OCT) scan of the macula is performed to monitor possible macular oedema. After application of anesthetic and midriatics drops, the patient is positioned on the chin and forhead support (ND: YAG laser). Then, a contact lens (panfundoscope) is filled with methylcellulose and placed on the cornea. The laser is focused on the opacity that is to be treated and the first laser stamp of an initial power of 3 mJ is applied. The measured direct effect will guide in further adjustment of the laser beam power to achieve the desired effect. After treatment, a single drop of corticosteroid is applied to the patient and an ocular patch is applied. On follow up days an OCT scan of the macula is performed to monitor possible side effects.

干预措施: Nd: YAG laser (Procedure)

结局指标

主要结局

Number of patients with resolution of symptoms

时间窗: 1 month

Number of patients who reported resolution of symptoms after the treatment

次要结局

  • Macular Oedema Development rate(1 month)
  • Rate of treatment side effects(1 month)
  • Retreatment rate(1 month)

研究者

发起方
University Hospital of Split
申办方类型
Other
责任方
Principal Investigator
主要研究者

Assist. prof. Ljubo Znaor, MD PhD

Principal Investigator

University Hospital of Split

研究点 (2)

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