|- candidate number||20891|
|- NTR Number||NTR4884|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-nov-2014|
|- Secondary IDs||NL50638.078.14 OZR-2014-17|
|- Public Title||Does positioning influence the progression of retinal detachment?|
|- Scientific Title||Does positioning influence the progression of retinal detachment?|
|- hypothesis||Posturing advise for patients with retinal detachment can be more selective.|
|- Healt Condition(s) or Problem(s) studied||Retinal detachment|
|- Inclusion criteria||Age ≥ 18 years |
Written informed consent
Sufficiently clear media to obtain an OCT scan
Sufficiently accurate OCT scan
RD with fovea on
RD involves the superotemporal quadrant
Central RD border is within the range of OCT imaging
Central RD border at ≥ 750 µm from the fovea
|- Exclusion criteria||None specified|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jan-2015|
|- planned closingdate||31-dec-2017|
|- Target number of participants||160|
|- Interventions||Interruption of supine bedrest by sitting upright for meals and other breaks, of progressive duration.|
|- Primary outcome||Unacceptable progression of RD (yes/no).|
Distance between RD and fovea (µm).
|- Secondary outcome||Age (years) |
Lens status (phakic/pseudophakic)
Best corrected visual acuity (0.2 to 1.2)
Spherical equivalent refraction (Diopter)
Extent of RD on fundus drawing and # detached quadrants (1/2/3/4)
Posterior vitreous detachment (PVD; yes/no)
Clock hours of retinal tears (0 to 12)
Type of RD (bullous/flat)
Posturing instruction (supine on the back/supine on the temporal side )
Date (yy:mm:dd) and time (hh:mm) of OCT scans.
(OCT-0: baseline, OCT-1a & OCT-1b: start & end of 1st interruption of supine bedrest, etc.)
Type of interruption and duration.
Start/end bedrest period 1
Start/end interruption 1
Start/end bedrest period 2
Start/end interruption 2
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. J.C. Meurs, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.C. Meurs, van|
|- Sponsor/Initiator ||Oogziekenhuis Rotterdam (OZR)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||de Jong JH, Vigueras-Guillén JP, Simon TC, Timman R, Peto T, Vermeer KA, van Meurs JC. Preoperative Posturing of Patients with Macula-On Retinal Detachment Reduces Progression Toward the Fovea. Ophthalmology. 2017; 124(10): 1510-1522.|
|- Brief summary||Rationale: Traditionally, patients with retinal detachment (RD) get posturing and positioning advise to prevent (or reduce) progression and, in particular, to prevent detachment of the fovea. Execution of such advise can be cumbersome and expensive. This study aims to acquire evidence which may corroborate such advise.|
Objective: To study whether positioning influences RD progression.
Study design: Comparative, non-randomized, non-parallel, unmasked trial.
Study population: Patients with RD.
Intervention: Prolongation of the interruption of bedrest (cohorts 1-3: +0, +15 and +30 min).
Main study parameters/endpoints: Proportion of unacceptable progression, change of the distance between the border of RD and fovea.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: OCT does not involve additional risk, burden is low. Unacceptable progression may be detected sooner and surgery can be rescheduled. Possibly the risk of foveal involvement is somewhat increased in cohorts 2 & 3.
|- Main changes (audit trail)|
|- RECORD||7-nov-2014 - 22-okt-2017|