|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00161525 |
|
Date of registration:
|
08/09/2005 |
|
Primary sponsor: |
|
|
Public title:
|
Pneumatic Displacement of Subretinal Hemorrhage With Perfluorocarbon Gases
|
|
Scientific title:
|
Perfluorocarbon Gases for the Repair of Retinal Detachments. |
|
Date of first enrolment:
|
October 2003 |
|
Target sample size:
|
25 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00161525 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Harvey Lincoff, MD |
|
Address:
|
|
|
Telephone:
|
212-962-6600 |
|
Email:
|
hal2005@med.cornell.edu |
|
Affiliation:
|
|
|
|
Name:
|
Harvey Lincoff, MD |
|
Address:
|
|
|
Telephone:
|
212-746-6600 |
|
Email:
|
hal2005@med.cornell.edu |
|
Affiliation:
|
|
|
|
Name:
|
Harvey Lincoff, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
New York Presbyterian Hospital, New York, NY 10021, United States |
|
|
Key inclusion & exclusion 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.
Age minimum:
20 Years
Age maximum:
95 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Subretinal Hemorrhage and Exudative Maculopathy
|
|
Intervention(s)
|
|
Procedure: Pneumatic displacement
|
|
Primary Outcome(s)
|
|
Displacement of Subretinal Hemorrhage
[Time Frame: 7 days after gas injection]
|
|
Secondary Outcome(s)
|
|
Improvement in visual acuity
[Time Frame: 7 days after gas injection]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|