Pneumatic Displacement of Subretinal Hemorrhage With Perfluorocarbon Gases

Subretinal Hemorrhage and Exudative Maculopathy Clinical Trial

Official title:

Perfluorocarbon Gases for the Repair of Retinal Detachments.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00161525
• Other study ID #: 1095-053
• Status: Recruiting
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: January 3, 2011
• Start date: October 2003
• Est. completion date: June 2009

Study information

• Verified date: January 2011
• Source: Weill Medical College of Cornell University
• Contact: Harvey Lincoff, MD
• Phone: 212-746-6600
• Email: hal2005[@]med.cornell.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 95 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Retinal Hemorrhage
• Subretinal Hemorrhage and Exudative Maculopathy

Intervention

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.

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	The Edward Grayson Fund for Retinal Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

Johnson MW. Pneumatic displacement of submacular hemorrhage. Curr Opin Ophthalmol. 2000 Jun;11(3):201-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Displacement of Subretinal Hemorrhage		7 days after gas injection	Yes
Secondary	Improvement in visual acuity		7 days after gas injection	No