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

Sponsor

Oogziekenhuis Rotterdam (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05344651

Collaborator

(none)

160

Enrollment

Location

Arms

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Device: Surgery/implantation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Baerveldt glaucoma drainage device	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.
Experimental: Paul glaucoma drainage device	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.

Arm

Intervention/Treatment

Active Comparator: Baerveldt glaucoma drainage device

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.

Experimental: Paul glaucoma drainage device

Device: Surgery/implantation

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 - 75 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:

Normal pressure glaucoma.
History of ocular surgery (e.g. intraocular or strabismus surgery, tenon's capsule or conjunctiva 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oogziekenhuis Rotterdam	Rotterdam		Netherlands	3011BH

Sponsors and Collaborators

Oogziekenhuis Rotterdam

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oogziekenhuis Rotterdam

ClinicalTrials.gov Identifier:

NCT05344651

Other Study ID Numbers:

OZR-2020-30
NL80518.078.22
MEC-2022-0069

First Posted:

Apr 25, 2022

Last Update Posted:

Apr 25, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Glaucoma

Study Results

No Results Posted as of Apr 25, 2022