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

Not Applicable

Recruiting

• Conditions: Glaucoma
• Interventions: Device: Surgery/implantation

• Registration Number: NCT05344651
• Lead Sponsor: Oogziekenhuis Rotterdam

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-25
• Study Start: 2022-10-19
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-13
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baerveldt glaucoma drainage device	Surgery/implantation	-
Paul glaucoma drainage device	Surgery/implantation	-

Primary Outcome Measures

Name	Time	Method
Change of endothelial cell density (ECD).	Baseline and 2 years	ECD will be assessed at the center of the cornea and close to the tube.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oogziekenhuis Rotterdam; 🇳🇱 Rotterdam, Netherlands