Recruiting
Phase 2

Pneumatic Displacement

Sponsor:

Weill Medical College of Cornell University

Code:

NCT00161525

Conditions

Subretinal Hemorrhage and Exudative Maculopathy

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Pneumatic displacement

Study Details

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.

Conditions

Subretinal Hemorrhage and Exudative Maculopathy

Study ID

NCT00161525

Start date

Oct, 2003

Status verified date

Jan, 2011

Completion date

Jun, 2009

Anticipated

Primary completion date

Jun, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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 The gas is withdrawn from a laboratory cylinder through a millipore filter and injected into the eye through a 30 gauge needle inserted 4.0 mm posterior to the limbus in the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.

Primary outcome measure

  • Displacement of Subretinal Hemorrhage [ Time Frame: 7 days after gas injection ]

Central Contacts and Locations

Central contacts

Harvey Lincoff, MD

212-746-6600hal2005@med.cornell.edu

Locations

New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10021

Contacts

Harvey Lincoff, MD

212-962-6600hal2005@med.cornell.edu

Principal Investigator:

Harvey Lincoff, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jan 4, 2011

Last verified

Jan, 2011

Keywords

  • Subretinal Hemorrhage, Perfluorocarbon gas

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2011-01-04.