Optic Nerve Sheath Fenestration

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Karen Joos, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00337961
First received: June 16, 2006
Last updated: January 6, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Optic Nerve Sheath Fenestration
Procedure: Optic Nerve Sheath Fenestration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optic Nerve Sheath Fenestration

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Histologic Evaluation [ Time Frame: Measured at time of procedure ] [ Designated as safety issue: No ]
  • Ease of Procedure [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]
  • Histological Evaluation [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2000
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Blind Eye Needing Enucleation

Exclusion Criteria:

  • Capable of being performed at FEL Surgical OR
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337961

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Study Director: Sandy A Owings, COA, CCRP Vanderbilt University
  More Information

No publications provided

Responsible Party: Karen Joos, Associate Professor of Ophthalmology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00337961     History of Changes
Other Study ID Numbers: 990379
Study First Received: June 16, 2006
Last Updated: January 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Optic Nerve Sheath Fenestration

ClinicalTrials.gov processed this record on July 23, 2014