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Pneumatic Displacement of Subretinal Hemorrhage With Perfluorocarbon Gases

Primary Purpose

Subretinal Hemorrhage and Exudative Maculopathy

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pneumatic displacement
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subretinal Hemorrhage and Exudative Maculopathy focused on measuring Subretinal Hemorrhage, Perfluorocarbon gas

Eligibility Criteria

20 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York Presbyterian HospitalRecruiting

Outcomes

Primary Outcome Measures

Displacement of Subretinal Hemorrhage

Secondary Outcome Measures

Improvement in visual acuity

Full Information

First Posted
September 8, 2005
Last Updated
January 3, 2011
Sponsor
Weill Medical College of Cornell University
Collaborators
The Edward Grayson Fund for Retinal Research
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1. Study Identification

Unique Protocol Identification Number
NCT00161525
Brief Title
Pneumatic Displacement of Subretinal Hemorrhage With Perfluorocarbon Gases
Official Title
Perfluorocarbon Gases for the Repair of Retinal Detachments.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2003 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
The Edward Grayson Fund for Retinal Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subretinal Hemorrhage and Exudative Maculopathy
Keywords
Subretinal Hemorrhage, Perfluorocarbon gas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Pneumatic displacement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Displacement of Subretinal Hemorrhage
Time Frame
7 days after gas injection
Secondary Outcome Measure Information:
Title
Improvement in visual acuity
Time Frame
7 days after gas injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harvey Lincoff, MD
Phone
212-746-6600
Email
hal2005@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvey Lincoff, MD
Organizational Affiliation
New York Presbyterian Hospital, New York, NY 10021, United States
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harvey Lincoff, MD
Phone
212-962-6600
Email
hal2005@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Harvey Lincoff, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
10977228
Citation
Johnson MW. Pneumatic displacement of submacular hemorrhage. Curr Opin Ophthalmol. 2000 Jun;11(3):201-6. doi: 10.1097/00055735-200006000-00009.
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Pneumatic Displacement of Subretinal Hemorrhage With Perfluorocarbon Gases

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