Optic Nerve Sheath Fenestration Clinical Trial
Official title:
Optic Nerve Sheath Fenestration
| Verified date | January 2013 |
| Source | Vanderbilt University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | December 2006 |
| Est. primary completion date | December 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Blind Eye Needing Enucleation Exclusion Criteria: - Capable of being performed at FEL Surgical OR |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Vanderbilt University | Nashville | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| Vanderbilt University | United States Department of Defense |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Histologic Evaluation | Measured at time of procedure | No | |
| Primary | Ease of Procedure | At time of procedure | No | |
| Primary | Histological Evaluation | At time of procedure | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04431882 -
The Role of Optic Nerve Sheath Fenestration in Leukemic Patients Having Increased Intracranial Pressure
|
Phase 2/Phase 3 |