|
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:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR2117 |
|
Date of registration:
|
23/11/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Posture or Patching (PoP).
Accelerated clearing of the media with massive vitreous hemorrhage and suspected retinal tear.
|
|
Scientific title:
|
Posture or Patching (PoP).
Accelerated clearing of the media with massive vitreous hemorrhage and suspected retinal tear.
- PoP |
|
Date of first enrolment:
|
1/1/2010 |
|
Target sample size:
|
80 |
|
Recruitment status: |
pending |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2117 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
J.C.
Meurs, van |
|
Address:
|
Oogziekenhuis Rotterdam,
Schiedamsevest 180, Schiedamsevest 180
3011 BH
Rotterdam
The Netherlands |
|
Telephone:
|
+31 (0)10 4017777 |
|
Email:
|
vanMeurs@oogziekenhuis.nl |
|
Affiliation:
|
|
|
|
Name:
|
J.C.
Meurs, van |
|
Address:
|
Oogziekenhuis Rotterdam,
Schiedamsevest 180, Schiedamsevest 180
3011 BH
Rotterdam
The Netherlands |
|
Telephone:
|
+31 (0)10 4017777 |
|
Email:
|
vanMeurs@oogziekenhuis.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Age ¡Ý 18 years;
2. Informed consent;
3. Vitreous hemorrhage (of spontaneous origin) totally obstructing visiblilty of the retina;
4. Suspicion of a retinal tear.
Exclusion criteria: 1. Retinal detachment (as demonstrated by ultrasonography);
2. Diabetic retinopathy;
3. Retinal veinous occlusion;
4. Allergy for eye bandage.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Vitreous hemorrhage
|
|
Intervention(s)
|
Group 1:
1. Instructions to maintain posture, i.e. in a sitting position at an angle of 45º, and;
2. Binocular occlusion.
Group 2:
1. Instructions to maintain posture, i.e. in a sitting position at an angle of 45º.
|
|
Primary Outcome(s)
|
1. Visibility of the superior retinal hemisphere at 20 h. (For the purpose of this study, visibility of the superior retina is defined as 4 clock hours or better); 2. Number of clock hours that is sufficiently visible;
3. Time interval between assuming prescribed posture and ophthalmoscopic examination on the day after presentation;
4. Use of anticoagulant drugs.
|
|
Secondary ID(s)
|
|
2009-07 / 2009-367
|
|
Source(s) of Monetary Support
|
|
Stichting Wetenschappelijk Onderzoek het Oogziekenhuis
|
|