Evaluation of pre-operative parameters in order to ascertain the need for a keratoplasty after cataract surgery has been performed in eyes with Fuchs* endothelial dystrophy.
ID
Source
Brief title
Condition
- Ocular structural change, deposit and degeneration NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Indication for keratoplasty within 1 year following cataract surgery, VA <= 0.4.
Time to decision for keratoplasty within 1 year following cataract surgery.
Secondary outcome
BCVA (ETDRS chart) after 2 and 12 months following cataract surgery.
Evaluation of two different techniques for pachymetry.
Background summary
Due to a limited amount of available data, no generally accepted criteria have
been defined for the ophthalmologist to decide how to treat a patient suffering
from Fuchs* endothelial dystrophy when cataract surgery becomes necessary. This
study aims to systematically collect data which, together with available data
from other studies, will asses the risk and risk factors for corneal
decompensation after cataract extraction in Fuchs* endothelial dystrophy.
Study objective
Evaluation of pre-operative parameters in order to ascertain the need for a
keratoplasty after cataract surgery has been performed in eyes with Fuchs*
endothelial dystrophy.
Study design
This is a prospective observational non-intervention study.
Study burden and risks
Fuchs patients due for cataract surgery are standardly scheduled for one pre-op
and three post-op visits. Study-related measurements will be performed during
the pre-op visit and the visits at 2 months and 1 year post-op. These will take
approximately 40 minutes extra time per visit. Participants of this study do
not benefit from the results of this study. Risks are negligible.
Schiedamse Vest 180
3011 BH Rotterdam
NL
Schiedamse Vest 180
3011 BH Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- Fuchs* endothelial dystrophy
- Indication for cataract surgery
- > 18 years of age
- BCVA < 0.5
Exclusion criteria
- Indication for Triple Procedure (e.g. far advanced grade III, by which cataract surgery alone would not be possible due to poor visualisation)
- Retinal disorders (e.g. age-related macular degeneration)
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 | NL17005.078.07 |