Vitreous Surgery With Intraocular Assistance
Status: | Terminated |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 100 |
Updated: | 9/28/2017 |
Start Date: | November 2015 |
End Date: | September 2017 |
Vitreous Surgery With Intraocular Assistance (VISIA)
To Assess the Safety of Vitreous surgery with intraocular assistance (VISIA) & to identify
and document with video evidence and surgeon's case report forms intraocular maneuvers that
are facilitated by VISIA.
and document with video evidence and surgeon's case report forms intraocular maneuvers that
are facilitated by VISIA.
Standard care surgery will be done with a few novel additions to facilitate the surgical
procedure. Currently 3 ports are inserted by creating holes in the sclera (white part of the
eye) to enter into the posterior part of the eye. When complex dissection is needed, a fourth
port will be inserted. The assistant will insert light source through the 4th port. This
eliminates the need for the surgeon to hold the light in one hand. Hence allows freeing of
both hands for the surgeon to use a forceps in one hand to grasp and elevate membranes and a
scissors in the other to cut connections between the retina and the membranes. When membranes
are particularly thick, it can be difficult to dissect with a single forceps holding up the
membrane. In this situation, a 5th port will be inserted allowing the assistant to insert a
light source through one and a forceps though another. The surgeon will have a forceps in one
hand and a scissors in another making dissection process more efficient.
procedure. Currently 3 ports are inserted by creating holes in the sclera (white part of the
eye) to enter into the posterior part of the eye. When complex dissection is needed, a fourth
port will be inserted. The assistant will insert light source through the 4th port. This
eliminates the need for the surgeon to hold the light in one hand. Hence allows freeing of
both hands for the surgeon to use a forceps in one hand to grasp and elevate membranes and a
scissors in the other to cut connections between the retina and the membranes. When membranes
are particularly thick, it can be difficult to dissect with a single forceps holding up the
membrane. In this situation, a 5th port will be inserted allowing the assistant to insert a
light source through one and a forceps though another. The surgeon will have a forceps in one
hand and a scissors in another making dissection process more efficient.
Inclusion Criteria:
All subjects must meet the following criteria to be eligible for study entry:
- Signed informed consent and authorization of use and disclosure of protected health
information
- Age ≥18 years
- Subject will have complex retinal pathology for which it is judged that surgical
objectives could be facilitated by VISIA
Exclusion Criteria:
Subjects who meet any of the following criteria will be ineligible for study entry:
• Patients with disease processes such as macular pucker and macular hole that are
generally well-managed by standard two-handed vitrectomy.
We found this trial at
1
site
Click here to add this to my saved trials
