Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium

Glaucoma Clinical Trial

Official title:

Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05344651
• Other study ID #: OZR-2020-30
• Secondary ID: NL80518.078.22ME
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: June 2026

Study information

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

Clinical Trial Summary

Rationale: The Baerveldt glaucoma drainage device (GDD) successfully reduces intraocular 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.

Objective: To determine whether the Paul tube induces less damage to the corneal endothelium than the Baerveldt GDD.

Study design: Randomized clinical trial. Study population: Phakic patients scheduled for surgical GDD implantation. Intervention: Either a Baerveldt or a Paul GDD implant. Main study parameters/endpoints: Endothelial cell density and tube position at 24 months.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age > 18 years.

• Informed consent.

• Caucasian ethnicity (to facilitate comparison of results with those of earlier work). Ethnicity will be based on self-reported origin of subject and/or parents.

• Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma.

Exclusion Criteria:

• History of intraocular surgery (e.g. vitrectomy, cataract 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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Surgery/implantation
The glaucoma drainage device consists of a plate and a tube. During surgery the plate is positioned underneath the conjunctiva and two extraocular muscles in the upper temporal quadrant of the eye. The tube is positioned in the anterior chamber.

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	Endothelial cell density (ECD).	ECD will be assessed at the center of the cornea and close to the tube.	Baseline, 3, 6, 12, 24 months.
Secondary	Intraocular pressure.	Intraocular pressure.	Baseline, 1, 3, 6, 12, 24 months.
Secondary	Orthoptic assessment.	Prism cover test: total deviation at 30 cm; Goldmann: monocular ductions in 8 directions starting from primary position, binocular field of single vision.	Baseline, 3, 6, 12, 24 months.