To demonstrate equivalence for ECD between Topcon SP-1P Specular microscope and Nidek Confoscan 4.
ID
Source
Brief title
Condition
- Eye disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
ECD
Secondary outcome
Level of agreement (LOA).
Coefficient of variance (CV).
Average cell size (ACS).
Hexagonality.
Background summary
The endothelial layer is vital for the condition of the cornea, and in
particular with disorders such as Fuchs Endothelial Dystrophy monitoring of
cell density is important. Unfortunately, however, convenience and reliability
of various methods to count endothelial cells do not coincide. In this study
the reliability of a new type of specular microscope will be compared to
confocal microscopy.
Study objective
To demonstrate equivalence for ECD between Topcon SP-1P Specular microscope and
Nidek Confoscan 4.
Study design
Prospective observational study.
Study burden and risks
Patients who are scheduled for a routine 6 months follow-up visit will be asked
to undergo two additional measurements, one of which (confocal microscopy) will
be *contact* in nature (touching the cornea). Participants do not benefit.
Information obtained in this study may help to improve monitoring of the
outcome of DSAEK.
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.
DSAEK performed.
Exclusion criteria
History of a intraocular glaucoma implant (e.g. Baerveldt).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50105.078.14 |