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.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Visibility of the superior retinal hemisphere.
Secondary outcome
None.
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.
Study objective
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
Study design: Randomized, open-label trial.
Intervention
Intervention: Instruction to maintain posture (group 1 & 2) and binocular
patching (group 2).
Study burden and risks
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.
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years.
- Informed consent.
- Vitreous hemorrhage (of spontaneous origin) totally obstructing visiblilty of the retina.
- Suspicion of a retinal tear.
Exclusion criteria
- Retinal detachment (as demonstrated by ultrasonography).
- Diabetic retinopathy with secundary neovascularization.
- Retinal veinous occlusion with secundary neovascularization.
- Allergy for eye bandage.
Design
Recruitment
Medical products/devices used
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 |
---|---|
CCMO | NL29682.078.09 |