Clinical trial NCT05500469: Endothelial Cell Loss in Pseudophakic Patients Receiving a Paul Glaucoma Drainage Device With Its Tube Inserted in the Anterior Versus Posterior Chamber: a Randomized Controlled Trial
Official title: Endothelial Cell Loss in Pseudophakic Patients Receiving a Paul Glaucoma Drainage Device With Its Tube Inserted in the Anterior Versus Posterior Chamber: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Lead sponsor: Oogziekenhuis Rotterdam
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rationale: 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.

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. Study population: Pseudophakic patients with glaucoma who need a GDD. Intervention: Implantation of a Paul GDD with its tube anterior/posterior of the iris. Main study parameters/endpoints: Endothelial cell loss of the cornea.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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).


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Informed consent
* Pseudophakic
* Open angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or angle closure glaucoma with sufficiently deep anterior chamber
* Endothelial image at baseline of fair or good quality

Exclusion Criteria:

* Iridocorneal endothelial syndrome or posterior polymorphous dystrophy
* Eyes with a history of penetrating trauma
* Eyes with a history of (intra)ocular surgery other than uncomplicated cataract surgery
* Eyes with corneal disease
* Synechiae posterior
* Pregnant and lactating women

Primary outcomes:
measure: Change of endothelial cell density (ECD)
timeFrame: Baseline and 2 years
Secondary outcomes:
measure: ECD
timeFrame: Baseline, 6, 12 and 24 months
measure: Intraocular pressure
timeFrame: Baseline, 1, 3, 6, 12 and 24 months
measure: Position of the tube
timeFrame: Baseline, 6, 12 and 24 months
measure: Adverse events
timeFrame: Time of surgery, 1, 3, 6, 12, 24 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Oogziekenhuis Rotterdam
Study officials:
References: