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

Glaucoma Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05500469
• Other study ID #: OZR-2022-03
• Secondary ID: NL81305.078.22ME
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: August 2026

Study information

• Verified date: December 2022
• Source: Oogziekenhuis Rotterdam
• Contact: Rene Wubbels
• Phone: +31104023430
• Email: r.wubbels[@]oogziekenhuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Paul glaucoma drainage device (GDD)
Implantation of the GDD

Locations

Country	Name	City	State
Netherlands	Oogziekenhuis Rotterdam	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Oogziekenhuis Rotterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of endothelial cell density (ECD)	ECD will be assessed at the center of the cornea and close to the tube	Baseline and 2 years
Secondary	ECD	ECD will be assessed at the center of the cornea and close to the tube	Baseline, 6, 12 and 24 months
Secondary	Intraocular pressure	Intraocular pressure	Baseline, 1, 3, 6, 12 and 24 months
Secondary	Position of the tube	Position of the tube on anterior segment OCT	Baseline, 6, 12 and 24 months
Secondary	Adverse events	Complications at the time of surgery, postoperative adverse events	Time of surgery, 1, 3, 6, 12, 24 months