No registrations found.
ID
Source
Health condition
Retinal detachment of the superior quadrants but with macula-on.
Sponsors and support
Postbus 70030
3000 LM Rotterdam
Postbus 93245
2509 AE Den Haag
Intervention
Outcome measures
Primary outcome
Unacceptable progression of RD (yes/no).
Distance between RD and fovea (µm).
Secondary outcome
Age (years)
Gender (M/F)
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.
Background 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.
Study objective
Posturing advise for patients with retinal detachment can be more selective.
Study design
Admission
Start/end bedrest period 1
Start/end interruption 1
Start/end bedrest period 2
Start/end interruption 2
Etcetera
Surgery
Intervention
Interruption of supine bedrest by sitting upright for meals and other breaks, of progressive duration.
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
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4755 |
| NTR-old | NTR4884 |
| CCMO | NL50638.078.14 |
| OMON | NL-OMON40661 |
Summary results
<br>
de Jong JH, de Koning K, den Ouden T, van Meurs JC, Vermeer KA. The Effect of Compliance With Preoperative Posturing Advice and Head Movements on the Progression of Macula-On Retinal Detachment. Transl Vis Sci Technol. 2019; 8(2):4.
<br>
Vroon J, de Jong JH, Aboulatta A, Eliasy A, van der Helm FCT, van Meurs JC,
Wong D, Elsheikh A. Numerical study of the effect of head and eye movement on
progression of retinal detachment. Biomech Model Mechanobiol. 2018; 17(4): 975-983.
<br>
de Jong JH, Vigueras-Guillen JP, Wubbels RJ, Timman, R, Vermeer KA, van Meurs JC. The influence of prolongation of interruptions of preoperative posturing and other clinical factors on the progress of macula-on retinal detachment. Ophthalmol Retina. 2019; 3: 938-946.