Primary: to determine the loss of corneal endothelial cells after implantation of a Paul GDD with its tube either anterior or posterior of the iris. Secondary: to compare efficacy and safety of both procedures.
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endothelial cell loss of the cornea.
Secondary outcome
Intraocular pressure.
Location of the tube.
Adverse events.
Background summary
Glaucoma is a group of diseases characterized by progressive neuropathy of the
optic nerve associated with visual field loss. Current glaucoma management aims
to preserve visual function throughout life by reducing the intraocular
pressure. This can be achieved by medical therapy or by surgical procedures
such as implantation of a glaucoma drainage device (GDD). Conventionally, the
tube of such a device is positioned in the anterior chamber (AC).
Unfortunately, the presence of the tube in the AC may have a significant
negative impact on the number of endothelial cells of the cornea and may even
lead to corneal decompensation. Alternatively, the tube can be positioned in
the posterior chamber (i.e. behind the iris). In this study, both procedures
will be compared.
Study objective
Primary: to determine the loss of corneal endothelial cells after implantation
of a Paul GDD with its tube either anterior or posterior of the iris.
Secondary: to compare efficacy and safety of both procedures.
Study design
Prospective, randomised, treatment controlled clinical trial.
Intervention
Implantation of a Paul GDD with its tube anterior/posterior of the iris.
Study burden and risks
At present potential benefits and drawbacks of positioning the Paul tube behind
the iris are insufficiently known, successful positioning of the tube may
require slightly more surgery time and the risk of hyphaema may be higher. It
is expected, that in the long run damage to the corneal endothelium is less.
Risks of study-related assessments are negligible, burden is low, extra time is
about 35+15+35+35 minutes (total 2h).
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Listed location countries
Age
Inclusion criteria
Pseudophakic.
Diagnosed with open angle glaucoma, pseudoexfoliation glaucoma, pigment
dispersion glaucoma or angle-closure glaucoma with a sufficiently deep AC.
Endothelial image at baseline of fair or good quality.
Exclusion criteria
Iridocorneal endothelial syndrome of posterior polymorphous dystrophy.
History of penetrating trauma.
History of intraocular surgery other than uncomplicated cataract surgery.
Corneal disease.
Pregnant and lactating women.
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 | NL81305.078.22 |