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

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 - Paul GDD-tube Positioning

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51545

Enrollment

200

Registered

2022-08-11

Start date

2022-10-20

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

corneal endothelium

Interventions

Implantation of a Paul GDD with its tube anterior/posterior of the iris.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Endothelial cell loss of the cornea.	—

Secondary

Measure	Time frame
Intraocular pressure. Location of the tube. Adverse events.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)