No registrations found.
ID
Source
Health condition
Glaucoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation between endothelial cell counts and tube position.
Secondary outcome
- Pachymetry.
- Cell morphology (polymegathism, pleomorphism).
- Stromal changes.
- Tube length.
- Tube bevel.
- Corneal decompensation.
Background summary
Rationale: 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.
Objective: To determine the effect of tube position in the anterior chamber on the corneal endothelium.
Study design: Prospective observational.
Study population: Glaucoma patients scheduled for a Baerveldt implant.
Main study parameter: Correlation between endothelial cell counts and tube position.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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).
Study objective
To determine the effect of tube position in the anterior chamber on the corneal endothelium.
Study design
pre-op, 1d,2w,6w,12m,24m
Intervention
none
Schiedamsevest 180
H.G. Lemij
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
Lemij@oogziekenhuis.nl
Schiedamsevest 180
H.G. Lemij
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
Lemij@oogziekenhuis.nl
Inclusion criteria
- Age 18-75 years.
- Informed consent.
- Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma.
Exclusion criteria
- History of intraocular surgery (i.e. strabismus surgery, tenon’s capsule or conjunctiva surgery, cataract surgery, cyclodestructive procedures etc.).
- History of ocular comorbidity (e.g. active uveitis, proliferative diabetic retinopathy).
- Pregnant or nursing women.
- Functionally monocular patients.
- Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, keratoplasty, or retinal surgery) or an anticipated need for additional ocular surgery.
- Best corrected visual acuity less than 0.1.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4823 |
| NTR-old | NTR4946 |
| CCMO | NL51175.078.14 |
| OMON | NL-OMON41928 |
Summary results
[Abstract]
van Kleij JM, Islamaj E, Vermeer KA, Lemij HG, de Waard PWT. The long-term postoperative effect of the Baerveldt glaucoma drainage device and of a trabeculectomy on the corneal endothelium. Acta Ophthalmol. 2022; 100(2): 212-217.
PMID: 33629525