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 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.

Study Overview

• Status: Completed
• Conditions: Optic Nerve Sheath Fenestration
• Intervention / Treatment: Procedure: Optic Nerve Sheath Fenestration

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Blind Eye Needing Enucleation

Exclusion Criteria:

• Capable of being performed at FEL Surgical OR

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Histologic Evaluation	Measured at time of procedure
Ease of Procedure	At time of procedure
Histological Evaluation	At time of procedure

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: United States Department of Defense
• Investigators: Study Director: Sandy A Owings, COA, CCRP, Vanderbilt University

Study record dates

Study Major Dates

• Study Start: July 1, 2000
• Primary Completion (ACTUAL): December 1, 2006
• Study Completion (ACTUAL): December 1, 2006

Study Registration Dates

• First Submitted: June 16, 2006
• First Submitted That Met QC Criteria: June 16, 2006
• First Posted (ESTIMATE): June 20, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 6, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Optic Nerve Sheath Fenestration
• Other Study ID Numbers: 990379