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Pneumatic Displacement of Subretinal Hemorrhage With Perfluorocarbon Gases

NCT00161525 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2011-01-04

No results posted yet for this study

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

Interventions

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 The gas is withdrawn from a laboratory cylinder through a millipore filter and injected into the eye through a 30 gauge needle inserted 4.0 mm posterior to the limbus in the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

Sponsors & Collaborators

  • The Edward Grayson Fund for Retinal Research

    collaborator UNKNOWN

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Harvey Lincoff, MD · New York Presbyterian Hospital, New York, NY 10021, United States

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00161525 on ClinicalTrials.gov