To study IVCM backscatter measurements as a usefull measurement to decide between surgical indications.
ID
Source
Brief title
Condition
- Eye disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Preoperative corneal backscatter; postoperative
number of patients requiring PLK (y/n).
Secondary outcome
Preoperative:
- LOCS III classification of cataract.
Preoperative and one month postoperative:
- 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.
Perioperative:
- Phaco time and energy.
Background summary
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.
Study objective
To study IVCM backscatter measurements as a usefull measurement to decide
between surgical indications.
Study design
Prospective observational trial.
Study burden and risks
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.
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.
- FED stage = 2.
- Cataract requiring surgery.
- Visual acuity (VA) < 0.7.
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.
- Amblyopia.
- Expected VA after surgery < 0.6.
- Fellow eye already included in this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL52626.078.15 |
| OMON | NL-OMON28829 |