Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338533
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2006-06-15
Brief Title:
Endoscopic Goniotomy for Infantile Glaucoma
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Endoscopic Goniotomy for Infantile Glaucoma
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Glaucoma surgery is performed on children less than 3 years old for infantile glaucoma which untreated can cause blindness Glaucoma is an uncontrolled high eye pressure in these children often due to incomplete development of the part of the eye which normally allows fluid to drain out of the eye Two procedures are possible and equal in their success of lowering the eye pressure However one the goniotomy procedure is preferred since it takes 10 minutes rather than 1 hour for the trabeculotomy procedure to perform under general anesthesia This is important in young children to reduce anesthesia exposure especially if both eyes need surgery If the glaucoma has caused the cornea or front of the eye to become too cloudy then the view is too poor to place a lens on the cornea and use a needle to perform the shorter procedure However a small endoscope which has been FDA approved for use in the eye will allow direct viewing of the area which needs treatment A needle attached to this endoscope allows the shorter goniotomy to be performed rather than proceeding to the longer trabeculotomy procedure The outcome measure of this study is anesthesia time and reduction in intraocular pressure
Detailed Description:
b The standard examination under anesthesia initially will be performed including measuring the childs intraocular pressure measuring dimensions of the eye examining the front of the eye under the operating microscope examining the portion of the eye where the fluid drains evaluating the back of the eye with an ultrasound and possible documentation with photographs
When the diagnosis is confirmed by this examination the eye or eyes will be carefully evaluated for their clarity If a standard goniotomy procedure can not be done then the endoscopic goniotomy will be performed The procedure is identical with cleaning the eyelid skin using a speculum to open the eyelids making a small cut into the cornea and placing a viscoelastic substance into the eye to maintain its shape The procedure then differs since the inserted needle is attached to the viewing endoscope I will then view the inside of the eye on a TV monitor in addition to looking through the operating microscope This will allow me to directly see the structures which I will need to cut Normally I depend upon looking through a lens placed on the cornea which must be fairly clear so that I can see to cut the structures in the standard procedure The procedure should not take much longer than the standard goniotomy and the same amount of tissue will be cut as in a standard goniotomy The needle is then removed The remainder of the procedure is identical which includes placing a stitch in the corneal incision adjusting the amount of fluid in the eye so the pressure is not too low or high giving a dilating drop giving a steroid and antibiotic injection around the eye giving steroid ointment and an eye patch
When the diagnosis is confirmed by this examination the eye or eyes will be carefully evaluated for their clarity If a standard goniotomy procedure can not be done then the endoscopic goniotomy will be performed The procedure is identical with cleaning the eyelid skin using a speculum to open the eyelids making a small cut into the cornea and placing a viscoelastic substance into the eye to maintain its shape The procedure then differs since the inserted needle is attached to the viewing endoscope I will then view the inside of the eye on a TV monitor in addition to looking through the operating microscope This will allow me to directly see the structures which I will need to cut Normally I depend upon looking through a lens placed on the cornea which must be fairly clear so that I can see to cut the structures in the standard procedure The procedure should not take much longer than the standard goniotomy and the same amount of tissue will be cut as in a standard goniotomy The needle is then removed The remainder of the procedure is identical which includes placing a stitch in the corneal incision adjusting the amount of fluid in the eye so the pressure is not too low or high giving a dilating drop giving a steroid and antibiotic injection around the eye giving steroid ointment and an eye patch
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None