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临床试验/NCT07062107
NCT07062107进行中(未招募)不适用

Study on the Application of Adaptive Fluidics Technique in the Surgery of Lens Diseases

Second Affiliated Hospital, School of Medicine, Zhejiang University2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2025年7月20日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
320
试验地点
2
主要终点
Real-time intraocular pressure changes during the operation

研究概览

简要总结

In phacoemulsification surgery for lens diseases using a traditional fluidics technology with a fixed perfusion pressure, the moment the perfusion needle enters the anterior chamber, the intraocular pressure will increase sharply. Moreover, the perfusion pressure cannot change along with the intraocular pressure during the operation, giving rise to many risks and threatening the safety of the surgery. The aim of this study is to apply adaptive fluidics technology to dynamically and precisely regulate the pressure and flow rate of the perfusion fluid, maintaining a relatively stable intraocular pressure during the operation. Meanwhile, intraoperative optical coherence tomography(OCT)was utilized to assist in observing the intraocular conditions, to study the advantages of adaptive fluidics technology in maintaining anterior chamber stability, and to verify the clinical application value of this technology in different types of lens diseases.

详细描述

Phacoemulsification is currently the most commonly used surgical method for lens diseases. During the operation, it is necessary to continuously deliver perfusion fluids such as balanced salt solution into the eye (anterior chamber) to maintain the depth of the anterior chamber and the stability of intraocular pressure. The perfusion pressure of the traditional fluidics system is constant, which may lead to problems such as a sudden increase in intraocular pressure at the moment the perfusion needle enters the eye, thereby increasing the surgical risk and affecting the surgical outcome. How to ensure that the intraocular pressure of patients remains relatively stable during surgery, optimize the surgical process and achieve a better prognosis has received extensive attention from ophthalmology practitioners and researchers. The emergence and application of adaptive fluidics can dynamically optimize the pressure and flow rate of perfusion fluid during surgery, significantly reduce intraocular pressure fluctuations, and enhance the stability of the anterior chamber. At present, the relevant research on the application of adaptive fluid flow technology to assist in lens disease surgery is still scarce. Its exact application value and practical advantages still need to be fully verified and elaborated in detail through clinical trials, follow-up observations and other links. The aim of this study is to apply adaptive fluidics technology to dynamically and precisely regulate the pressure and flow rate of the perfusion fluid, maintaining a relatively stable intraocular pressure during the operation. Meanwhile, intraoperative optical coherence tomography(OCT)was utilized to assist in observing the intraocular conditions, to study the advantages of adaptive fluidics technology in maintaining anterior chamber stability, and to verify the clinical application value of this technology in different types of lens diseases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with lens opacity or abnormal position, with or without anterior segment structural changes, who meet the surgical indications and are aged between 18 and 80 years old and require lens surgery.

排除标准

  • The patient has severe corneal scars or other corneal lesions, intraocular inflammation, and lesions of the retina, choroid, optic nerve, etc. that seriously affect the prognosis of vision. The patient has a clear history of systemic diseases affecting vision, a history of systemic medication, concurrent retinopathy, and other contraindications for conventional lens surgery.

结局指标

主要结局

Real-time intraocular pressure changes during the operation

时间窗: During the operation

The variation range of intraocular pressure during phacoemulsification surgery, especially the intraocular pressure at the moment when the perfusion needle enters the anterior chamber.

Quantify the measured values of ultrasonic energy exposure

时间窗: During the operation

Including average phacoemulsification energy, average phacoemulsification power, effective phacoemulsification time and total phacoemulsification time.

The volume of perfusion fluid used during the operation

时间窗: During the operation

Including average perfusion time, average aspiration time, average flow rate and total liquid usage.

Intraoperative OCT-assisted observation of anterior chamber depth changes

时间窗: During the operation

Using intraoperative OCT to evaluate the distance between the pupil margin and the corneal endothelium to measure the changes in anterior chamber depth.

次要结局

  • Technical indicators related to anterior segment OCT during the operation(During the operative)
  • Intraocular pressure(1day, 1 week, 1 month and 3 month postoperation)
  • Successful implantation rate of intraocular lens(Through study completion, an average of 1 year)
  • Intraocular lens position after implantation(1day, 1 week and 1 month postoperation)
  • Visual function(1day, 1 week, 1 month and 3month postoperation)
  • Postoperative complication(1 week, 1 month and 3month postoperation)
  • Technical indicators related to anterior segment OCT during the operation(During the operative)
  • Successful implantation rate of intraocular lens(Through study completion, an average of 1 year)
  • Intraocular lens position after implantation(1day, 1 week and 1 month postoperation)
  • Visual function(1day, 1 week, 1 month and 3month postoperation)
  • Postoperative complication(1 week, 1 month and 3month postoperation)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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