Pneumatic Displacement of Subretinal Hemorrhage With Perfluorocarbon Gases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00161525|
Recruitment Status : Unknown
Verified January 2011 by Weill Medical College of Cornell University.
Recruitment status was: Recruiting
First Posted : September 12, 2005
Last Update Posted : January 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Subretinal Hemorrhage and Exudative Maculopathy||Procedure: Pneumatic displacement||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Perfluorocarbon Gases for the Repair of Retinal Detachments.|
|Study Start Date :||October 2003|
|Estimated Primary Completion Date :||June 2009|
|Estimated Study Completion Date :||June 2009|
- Procedure: Pneumatic displacement
Pneumatic displacement of the subretinal hemorrhages is attempted with an intravitreous injection of 0.4 ml of pure C2F6 or 2 injections of 0.2 ml on subsequent days. The gas is withdrawn from a laboratory cylinder through a millipore filter and injected into the eye through a 30 gauge needle inserted 4.0 mm posterior to the limbus in the superior temporal quadrant. The tip of the needle is monitored in the vitreous by indirect ophthalmology prior to injecting the gas.Post injections the central retinal artery is examined whether is patent.The intraocular gas expands 3.3 times over the next 3 days to create a 40% bubble.The patient is asked to assume a gaze position 40° below the horizontal for 20 minutes every hour while awake and to sleep on 2 pillows with his head turned to the right.
- Displacement of Subretinal Hemorrhage [ Time Frame: 7 days after gas injection ]
- Improvement in visual acuity [ Time Frame: 7 days after gas injection ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161525
|Contact: Harvey Lincoff, MDfirstname.lastname@example.org|
|United States, New York|
|New York Presbyterian Hospital||Recruiting|
|New York, New York, United States, 10021|
|Contact: Harvey Lincoff, MD 212-962-6600 email@example.com|
|Principal Investigator: Harvey Lincoff, MD|
|Principal Investigator:||Harvey Lincoff, MD||New York Presbyterian Hospital, New York, NY 10021, United States|