|- candidate number||22265|
|- NTR Number||NTR5198|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-jun-2015|
|- Secondary IDs||NL52626.078.15 OZR-2015-02|
|- Public Title||Cataract surgery with FED|
|- Scientific Title||Clinical decision making in patients with cataract and Fuchs¡¯ endothelial dystrophy (FED): validation of in vivo confocal microscopy backscatter and OCT as a predictive measurements to decide to perform a phaco- or triple procedure.|
|- hypothesis||In vivo confocal microscopy (IVCM) backscatter measurements is a usefull measurement to decide whether patients with FED and cataract should undergo either a phaco or a triple procedure.|
|- Healt Condition(s) or Problem(s) studied||Fuchs'endothelial dysthrophy, Cataract|
|- Inclusion criteria||- Age ¡İ 18 years.|
- Informed consent.
- FED stage ¡İ 2.
- Cataract requiring surgery.
- Visual acuity (VA) < 0.5.
|- Exclusion criteria||- Indication for triple procedure.|
- History of other ocular disorders affecting VA.
- History of intra-ocular, corneal or refractive surgery.
- Severe nystagmus.
- Corneal opacity in the pre-pupillary region not related to FED.
- Corneal neovascularization > 1 quadrant.
- Expected VA after surgery < 0.6.
- Fellow eye already included in this study.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||3-jun-2015|
|- planned closingdate||31-mei-2018|
|- Target number of participants||80|
|- Primary outcome||At one month: the number of patients (not) requiring posterior lamellar keratoplasty (PLK); this in relation to the preoperatively measured corneal backscatter (on in vivo confocal microscope).
|- Secondary outcome||- OCT grayscale of the corneal stroma.|
- Best corrected visual acuity (BCVA; ETDRS).
- Pachymetry (Tomey).
- Contrast sensitivity (CS; Pelli-Robson).
- Straylight (C-Quant).
- VFQ-25 questionnaire.
|- Timepoints||Preop, 1 month.|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| The Rotterdam Eye Hospital |
|- CONTACT for SCIENTIFIC QUERIES|| J. Rooij, van|
|- Sponsor/Initiator ||The Rotterdam Eye Hospital|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: Fuchs endothelial dystrophy (FED) is associated with a reduction of the corneal endothelial cell density (ECD). As cataract surgery may enhance cell loss, and lead to corneal edema and reduced vision, it may become necessary to restore vision by posterior lamellar keratoplasty (PLK). With advanced FED, the ECD itself happens to be an unreliable parameter. Instead, we will evaluate backscatter on in vivo confocal microscopy (IVCM) as a possible decisive preoperative measure for the clinical choice between phaco-emulsification or triple procedure in eyes with FED and cataract.|
Objective: To study IVCM backscatter measurements as a usefull measurement to decide between surgical indications.
Study design: Prospective observational trial.
Study population: Patients with advanced FED indicated for cataract surgery.
Main study parameters/endpoints: Preoperative corneal backscatter; postoperative
number of patients requiring PLK (y/n).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Particpants do not benefit. Assessments will be scheduled at the time of regular visits. Additional measurements include two IVCM assessments which involve contact with the cornea. Extra measurements will take about two times one hour.
|- Main changes (audit trail)|
|- RECORD||2-jun-2015 - 25-jul-2015|