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Posture or Patching (PoP).
Accelerated clearing of the media with massive vitreous hemorrhage and suspected retinal tear.



- candidate number6745
- NTR NumberNTR2117
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-nov-2009
- Secondary IDs2009-07 / 2009-367 OZR / MEC
- Public TitlePosture or Patching (PoP).
Accelerated clearing of the media with massive vitreous hemorrhage and suspected retinal tear.
- Scientific TitlePosture or Patching (PoP).
Accelerated clearing of the media with massive vitreous hemorrhage and suspected retinal tear.
- ACRONYMPoP
- hypothesisBinocular patching in combination with posture adherence is superior to posture adherence alone in achieving visualization of the superior fundus quadrants following a vitreous hemorrhage.
- Healt Condition(s) or Problem(s) studiedVitreous hemorrhage
- Inclusion criteria1. Age 18 years;
2. Informed consent;
3. Vitreous hemorrhage (of spontaneous origin) totally obstructing visiblilty of the retina;
4. Suspicion of a retinal tear.
- Exclusion criteria1. Retinal detachment (as demonstrated by ultrasonography);
2. Diabetic retinopathy;
3. Retinal veinous occlusion;
4. Allergy for eye bandage.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate31-dec-2011
- Target number of participants80
- InterventionsGroup 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�.
- Primary outcome1. 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 outcomeN/A
- Timepoints1. Admittance to the hospital;
2. Next morning.
Time interval between presentation & ophtalmoscopic examination is 12-24 hours.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. J.C. Meurs, van
- CONTACT for SCIENTIFIC QUERIESDr. J.C. Meurs, van
- Sponsor/Initiator Oogziekenhuis Rotterdam (OZR)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek het Oogziekenhuis
- PublicationsN/A
- Brief summaryRationale:
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.
- Main changes (audit trail)
- RECORD23-nov-2009 - 22-okt-2017


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