To detemine whether the Paul tube induces less damage to the corneal endothelium than the Baerveldt GDD.
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endothelial cell density and tube position at 24 months.
Secondary outcome
Intraocular pressure
Motility
Flare
Background summary
The Baerveldt glaucoma drainage device (GDD) successfully reduces introacular
pressure but also involves a risk of corneal endothelial deterioration.
Supposedly, the tip of a GDD tube with a thinner diameter, such as the Paul
implant, will remain at a larger distance from the cornea and, thereby, cause
less damage.
Study objective
To detemine whether the Paul tube induces less damage to the corneal
endothelium than the Baerveldt GDD.
Study design
Randomized clinical trial.
Intervention
Either a Baerveldt or a Paul GDD implant.
Study burden and risks
The Paul GDD may have a less harmful effect on corneal endothelium. Otherwise,
both GDDs will probably have a similar risk/benefit profile. The risks of
study-related assessments are negligible, burden is low, extra time is about 5
x 1.5 h (total 7.5 h).
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Listed location countries
Age
Inclusion criteria
Age 18 - 75 years.
Caucasian ethnicity (to facilitate comparison of results with those of earlier
work).
Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary
glaucoma.
Exclusion criteria
Normal pressure glaucoma.
History of ocular surgery (e.g. intraocular or strabismus surgery, tenon*s
capsule or conjunctiva surgery, cyclodestructive procedures etc).
History of ocular comorbidity (e.g. active uveitis, proliferative diabetic
retinopathy).
Pseudophakia.
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.
Narrow anterior chamber angle.
Best corrected visual acuity less than 0.1.
Severe blepharitis.
Design
Recruitment
Medical products/devices used
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 | NL80518.078.22 |