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Pneumatic Displacement of Subretinal Hemorrhage With Perfluorocarbon Gases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Edward Grayson Fund for Retinal Research
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00161525
First received: September 8, 2005
Last updated: January 3, 2011
Last verified: January 2011
  Purpose

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 recommended.A 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.


Condition Intervention Phase
Subretinal Hemorrhage and Exudative Maculopathy
Procedure: Pneumatic displacement
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Perfluorocarbon Gases for the Repair of Retinal Detachments.

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Displacement of Subretinal Hemorrhage [ Time Frame: 7 days after gas injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in visual acuity [ Time Frame: 7 days after gas injection ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: October 2003
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

  Eligibility

Ages Eligible for Study:   20 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diminished vision secondary to subretinal hemorrhage in the macula or exudative maculopathy.

Exclusion Criteria:

  • Patient unable to maintain gaze position for 20 minutes every waking hour for 7 days.
  • Patient unable to sleep on their side or with head elevated 40 degrees.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161525

Contacts
Contact: Harvey Lincoff, MD 212-746-6600 hal2005@med.cornell.edu

Locations
United States, New York
New York Presbyterian Hospital Recruiting
New York, New York, United States, 10021
Contact: Harvey Lincoff, MD    212-962-6600    hal2005@med.cornell.edu   
Principal Investigator: Harvey Lincoff, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
The Edward Grayson Fund for Retinal Research
Investigators
Principal Investigator: Harvey Lincoff, MD New York Presbyterian Hospital, New York, NY 10021, United States
  More Information

Publications:
Responsible Party: Harvey A. Lincoff M.D., Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00161525     History of Changes
Other Study ID Numbers: 1095-053
Study First Received: September 8, 2005
Last Updated: January 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Subretinal Hemorrhage, Perfluorocarbon gas

Additional relevant MeSH terms:
Hemorrhage
Retinal Hemorrhage
Eye Diseases
Eye Hemorrhage
Pathologic Processes
Retinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014