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NCT00337961 · ClinicalTrials.gov registry record · NA
Optic Nerve Sheath Fenestration
A NA study, sponsored by Vanderbilt University.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT00337961 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 20 participants.
The verdict
NCT00337961, a NA study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
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 specifi
Interventions
- PROCEDURE Optic Nerve Sheath Fenestration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2000-07 |
| Est. Completion | 2006-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00337961
The ClinicalTrials.gov registry entry for NCT00337961 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Optic Nerve Sheath Fenestration is the first listed.
NCT00337961 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00337961 about?
NCT00337961 is a clinical study titled "Optic Nerve Sheath Fenestration". 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...
What is the current status of trial NCT00337961?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2000-07. Estimated completion is 2006-12.
What interventions are being tested in trial NCT00337961?
The interventions under investigation include: Optic Nerve Sheath Fenestration (PROCEDURE).
Who is sponsoring clinical trial NCT00337961?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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