No registrations found.
ID
Source
Brief title
Health condition
Vitreous hemorrhage.
Sponsors and support
PO Box 70030
3000 LM Rotterdam
Intervention
Outcome measures
Primary outcome
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 outcome
N/A
Background summary
Rationale:
About 30-40% of the cases of vitreous hemorrhage are, supposedly, caused by posterior vitreous detachment (PVD) and retinal breaks. Diagnostics are complicated because a sufficiently dense vitreous hemorrhage obstructs the ophthalmologist's funduscopic inspection, and detection of a retinal tear by ultrasonographic examination is not sufficiently reliable. Therefore, the choice between instant vitrectomy, delayed vitrectomy or regular monitoring remains erratic. If no (initial) signs of retinal tear or detachment are observed, the patient is instructed to restrict physical activity and maintain an upright position, and to return for periodic evaluation. This observational policy may, however, lead to a delay of treatment and an increased risk of developing retinal detachment which may result in a relatively poor outcome. It is conjectured that binocular occlusion accelerates the clearing of an obscured fundus.
Objective:
To investigate whether binocular patching in combination with posture adherence is superior to posture adherence alone in achieving visualization of the superior fundus quadrants or not.
Study design:
Randomized, open-label trial.
Study population:
Patients with vitreous hemorrhage obstructing retinal visiblilty.
Intervention:
Instruction to maintain posture (group 1 & 2) and binocular patching (group 2).
Main study parameters/endpoints:
Visibility of the superior retinal hemisphere.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients assigned to group 2 will be subjected to regular treatment. They will neither benefit nor be exposed to any extra risk. Patients assigned to group 1 may experience patching of their eyes for upto 24 hours, although not involving any risk, as rather inconvenient. If the probability of fundus visibility increases, and an accurate diagnosis is established earlier, this would be beneficial.
Study objective
Binocular patching in combination with posture adherence is superior to posture adherence alone in achieving visualization of the superior fundus quadrants following a vitreous hemorrhage.
Study design
1. Admittance to the hospital;
2. Next morning.
Time interval between presentation & ophtalmoscopic examination is 12-24 hours.
Intervention
Group 1:
1. Instructions to maintain posture, i.e. in a sitting position at an angle of 45�, and;
2. Binocular occlusion.
Group 2:
1. Instructions to maintain posture, i.e. in a sitting position at an angle of 45�.
Schiedamsevest 180
J.C. Meurs, van
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
vanMeurs@oogziekenhuis.nl
Schiedamsevest 180
J.C. Meurs, van
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
vanMeurs@oogziekenhuis.nl
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL2000 |
NTR-old | NTR2117 |
Other | OZR / MEC : 2009-07 / 2009-367 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
RJ, Manning S, La Heij EC, van Meurs JC. STRICT POSTURING WITH OR WITHOUT
BILATERAL PATCHING FOR POSTERIOR VITREOUS DETACHMENT-RELATED VITREOUS HEMORRHAGE.
Retina. 2020; 40(6): 1169-1175.
PubMed PMID: 31136460.