To determine the effect of tube position in the anterior chamber on the corneal endothelium.
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation between endothelial cell counts and tube position.
Secondary outcome
Pachymetry.
Cell morphology.
Stromal changes.
Tube length.
Corneal decompensation.
Background summary
Implantation of the Baerveldt glaucoma drainage device is a common procedure
for glaucoma management. A silicon tube is then put in the anterior chamber of
the eye. Postoperative corneal endothelial changes, notably a reduction in
endothelial cell count are quite common, sometimes leading to corneal
decompensation requiring corneal transplant surgery. It is unclear to what
extent tube position in the anterior chamber plays a role in the pathogenesis
of the corneal changes.
Study objective
To determine the effect of tube position in the anterior chamber on the corneal
endothelium.
Study design
Prospective observational.
Study burden and risks
Participation does not involve any additional risk. Burden is limited to the
additional time needed for extra measurements. These assessments will be
performed at the time of regular visits and take about one hour extra time
(5X).
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Listed location countries
Age
Inclusion criteria
Age 18-80 years.
Informed consent.
Primary open-angle glaucoma, pseudoexfoliative glaucoma, pigmentary glaucoma or normal tension glaucoma.
Exclusion criteria
History of corneal diseases (e.g. Fuchs* endothelial dystrophy, HSV keratitis).
Cataract surgery less than 12 months before.
History of ocular comorbidity.
Functionally monocular patients.
Need for glaucoma surgery combined with other ocular procedures or an anticipated need for additional ocular surgery.
Best corrected visual acuity less than 0.1.
Study eye received Baerveldt implant before.
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 | NL51175.078.14 |
| OMON | NL-OMON29065 |