Pneumatic Displacement of Subretinal Hemorrhage With Perfluorocarbon Gases

NCT ID: NCT00161525

Last Updated: 2011-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2009-06-30

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

Conditions

Subretinal Hemorrhage and Exudative Maculopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Edward Grayson Fund for Retinal Research

UNKNOWN

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Weill Cornell Medical College

Principal Investigators

Harvey Lincoff, MD

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian Hospital, New York, NY 10021, United States

Locations

New York Presbyterian Hospital

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Harvey Lincoff, MD

Role: CONTACT

hal2005@med.cornell.edu

212-746-6600

Facility Contacts

Harvey Lincoff, MD

Role: primary

hal2005@med.cornell.edu

212-962-6600

References

Johnson MW. Pneumatic displacement of submacular hemorrhage. Curr Opin Ophthalmol. 2000 Jun;11(3):201-6. doi: 10.1097/00055735-200006000-00009.

Reference Type: BACKGROUND

PMID: 10977228 (View on PubMed)

Other Identifiers

1095-053

Identifier Type: -

Identifier Source: org_study_id