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临床试验/NCT00337961
NCT00337961已完成不适用

Optic Nerve Sheath Fenestration

Vanderbilt University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2000年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Histologic Evaluation

研究概览

简要总结

The purpose of this study is to develop a way to perform safer surgery in the eye socket. The eye and its surrounding structures are very delicate and can easily be damaged from surgery. A laser may act as a gentle knife to cut the tissue. Currently, this is done with a small scissors and knife, but it could be done with gentle laser. By using an endoscope, the surgery could be much safer and faster. Vanderbilt has a Free Electron Laser, which could be used to make a small hole in the coverings around the optic nerve to treat certain diseases. Before it is used in seeing eyes, the laser must be tested on eyes which are to be removed during an enucleation to prove that it does not damage the optic nerve The standard enucleation (removal of your blind painful eye) will be performed. This procedure will be performed at the Free Electron Laser Center Operating Room, which is a fully equipped operating room currently being used for outpatient surgery. The post-operative recovery room setting is similar to the post-operative recovery room in the previously used area. This includes general anesthesia with a breathing tube in your throat, injecting an anesthetic liquid behind the eye for comfort after surgery, and removing the eyeball. Enucleations must be performed under general anesthesia or intravenous sedation with a retrobulbar injection (injection behind the eye). The anesthesiologist will determine which is safer to perform. The removed globe will be replaced with a spherical implant. Just prior to the removal of the eyeball, a small opening will be made in the coverings around your optic nerve (the cable exiting the eyeball) with the endoscopic laser or with a knife and scissors. The procedure should not take much longer than the standard eye removal. The procedure will be identical to the standard enucleation (eye removal) except for making the tiny hole in the coverings of the optic nerve, which should take about 15 to 30 minutes.

The laser is very tissue specific. It only reacts with certain types of tissue and should not damage the surrounding tissue.

There will be no additional costs to you associated with the study portion of the procedure.

详细描述

The purpose of this study is to develop a way to perform safer surgery in the eye socket. The eye and its surrounding structures are very delicate and can easily be damaged from surgery. A laser may act as a gentle knife to cut the tissue. Currently, this is done with a small scissors and knife, but it could be done with gentle laser. By using an endoscope, the surgery could be much safer and faster. Vanderbilt has a Free Electron Laser, which could be used to make a small hole in the coverings around the optic nerve to treat certain diseases. Before it is used in seeing eyes, the laser must be tested on eyes which are to be removed during an enucleation to prove that it does not damage the optic nerve The standard enucleation (removal of your blind painful eye) will be performed. This procedure will be performed at the Free Electron Laser Center Operating Room, which is a fully equipped operating room currently being used for outpatient surgery. The post-operative recovery room setting is similar to the post-operative recovery room in the previously used area. This includes general anesthesia with a breathing tube in your throat, injecting an anesthetic liquid behind the eye for comfort after surgery, and removing the eyeball. Enucleations must be performed under general anesthesia or intravenous sedation with a retrobulbar injection (injection behind the eye). The anesthesiologist will determine which is safer to perform. The removed globe will be replaced with a spherical implant. Just prior to the removal of the eyeball, a small opening will be made in the coverings around your optic nerve (the cable exiting the eyeball) with the endoscopic laser or with a knife and scissors. The procedure should not take much longer than the standard eye removal. The procedure will be identical to the standard enucleation (eye removal) except for making the tiny hole in the coverings of the optic nerve, which should take about 15 to 30 minutes.

The laser is very tissue specific. It only reacts with certain types of tissue and should not damage the surrounding tissue.

There will be no additional costs to you associated with the study portion of the procedure.

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
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

  • Blind Eye Needing Enucleation

排除标准

  • Capable of being performed at FEL Surgical OR

结局指标

主要结局

Histologic Evaluation

时间窗: Measured at time of procedure

Ease of Procedure

时间窗: At time of procedure

Histological Evaluation

时间窗: At time of procedure

次要结局

未报告次要终点

研究者

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

Karen Joos

Associate Professor of Ophthalmology

Vanderbilt University

研究点 (2)

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