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临床试验/NCT03908515
NCT03908515Unknown不适用

Multi-center Clinical Observation of FCVB in Guangdong Province

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Ocular protrusion change

研究概览

简要总结

This study provides further theoretical guidance for clinical application of FCVB through observing and collecting various indicators before and after surgical treatment of the FCVB in the real world.

详细描述

  1. Research purpose: Collect and analyze the medical data in clinical work, in order to provide further theoretical guidance for the clinical application of FCVB.
  2. Inclusion criteria: 1) Patients with severe retinal detachment, cannot be cured with existing vitreous substitutes, and are scheduled for FCVB implantation surgery; 2) Patients with silicone oil dependent eye, silicone oil emulsification, and chooses FCVB surgery; 3) Patients whose eyeball Atrophy, and strongly demand eye protection.
  3. Exclusion criteria: 1) Patients with positive urine pregnancy test; 2) Patients with FCVB removed and switched to other alternative treatments; 3) Patients the investigator consider are not suitable for this clinical trial.
  4. Endpoint Primary endpoint: Changes in corneal transverse diameter and ocular protrusion after 1 year of FCVB implantation.

Secondary endpoints: visual acuity and intraocular pressure; local inflammatory response and complications evaluation; satisfaction investigated by questionnaire survey. 5. Process Before surgery, collecting the patient's medical history and pre-operative related specialist examination data and subjective opinions of doctors on surgical indications. Recording the surgical procedure, intraoperative complications. After surgery (3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year and 1 year follow-up every year), using visual acuity chart, slit lamp microscope, ophthalmoscope, intraocular pressure, Hertel exophthalmometer, vernier caliper to observe the patient's visual acuity, local inflammatory reaction, intraocular pressure and eyeball atrophy changes. 6. Efficacy evaluation Main indicators: the changes of corneal transverse diameter and ocular protrusion were observed 1 year after FCVB implantation.

Secondary indicators: visual acuity and intraocular pressure; local inflammatory response and complications evaluation; satisfaction investigated through questionnaire survey. 7. Safety evaluation Adverse events that occurred during all studies. 8. Termination criteria During the clinical trial, the clinical trial shall be terminated in any of the following cases; (1) FCVB cannot be implanted (2) Subjects who fail to comply with the program requirements (including loss of follow-up) are subject to termination by the study physician; (3) a female patient who is intentionally pregnant or a female subject who has been confirmed to have been pregnant; (4) Participated in other clinical trials after participating in this clinical trial; (5) Adverse events or serious adverse events occurred during the trial and were unable to continue participating in the study; (6) The subject withdraws the informed consent or requests termination of the trial for some objective reason.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Patients with the diagnose that severe retinal detachment and cannot be cured with existing vitreous substitutes, or silicone oil dependent eye accompanied with silicone oil emulsification, or eyeball atrophy meanwhile patients strongly demand keeping eyeball.
  • Patients agree to receive FCVB implantation surgery.

排除标准

  • Patients whose urine pregnancy test are positive.
  • Patients whose FCVB have been removed and switched to other alternative treatments.
  • Patients whom the investigator consider are not suitable for this clinical trial.

结局指标

主要结局

Ocular protrusion change

时间窗: Ocular protrusion change from 1day before surgery to 1 year after surgery

Determine the degree of eyeball atrophy through the ocular protrusion change

Corneal transverse diameter change

时间窗: Corneal transverse diameter change from 1day before surgery to 1 year after surgery

Determine the degree of eyeball atrophy through the change of transverse Diameter of the cornea

次要结局

  • Local inflammatory response(3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery)
  • Visual acuity(3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery)
  • Patients satisfaction(3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery)
  • Intraocular pressure(3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaofeng Lin

associate dean of Zhongshan Ophthalmic Center, Sun Yat-sen University

Sun Yat-sen University

研究点 (1)

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