Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161525
Status:
UNKNOWN
Last Update Posted:
2011-01-04
First Post:
2005-09-08
Brief Title:
Pneumatic Displacement of Subretinal Hemorrhage With Perfluorocarbon Gases
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Perfluorocarbon Gases for the Repair of Retinal Detachments
Status:
UNKNOWN
Status Verified Date:
2011-01
Last Known Status:
RECRUITING
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:
Subretinal hemorrhage in the macula causes a significant loss of vision This hemorrhage can be displaced by the use of a small volume of pure perfluorocarbon gas injected into the vitreous which expands to a 40 gas bubble in the eye When the patient gazes 40 to 60 degree below the horizontal the gas bubble covers the hemorrhage and gravity displaces it rapidly This position of gaze is easier for the patient than the face down position traditionally recommendedA vector of gravity force tangential to the sclera brings about this displacement The procedure can improve vision quickly reduce unwanted degenerative changes in the macula because of the persistent macular hemorrhage and improves the chances of treating of the underlying cause for the subretinal hemorrhage by laser or other means
Detailed Description:
This protocol was designed to determine the optimum position of the gaze for pneumatic displacement of subretinal hemorrhage SRH in the macula A geometrical analysis of the forces that act upon a SRH in the presence of an intraocular gas bubble was analyzed and it was concluded that the displacement was due to the effect of gravity on the SRH immersed in gas This was followed by a prospective trial of positions of gaze and volumes of gas calculated to be optimum for displacement The eyes of consecutive patients with SRH in the macula will had an intravitreal injection of pure perfluorocarbon gas sufficient to provide a 40 bubble after expansion The patients are instructed to gaze down 40 or 60 below the horizontal depending on the volume of gas for 20 minutes every hour The SRH is displaced rapidly in the first week Visual acuity usually improves but recovery can be limited by the presence of sub pigment epithelial hemorrhage exudate or proliferation A vector of the gravity force tangential to the sclera is the largest force acting to displace a subretinal hemorrhage within a gas bubble 79 of the vertical gravity component is obtained at gaze 40 below the horizontal and requires volumes of intraocular gas not requiring prior removal of vitreous Face down positioning in common practice has been an error and succeeds only if the patient has been non compliant
5- STATUS
5- STATUS
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