NCT05344651

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Oct 2022Jun 2026

First Submitted

Initial submission to the registry

April 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

October 19, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

3.6 years

First QC Date

April 19, 2022

Last Update Submit

December 12, 2022

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Endothelial cell density (ECD).

    Baseline, 3, 6, 12, 24 months.

  • Intraocular pressure.

    Baseline, 1, 3, 6, 12, 24 months.

  • Orthoptic assessment.

    Baseline, 3, 6, 12, 24 months.

Study Arms (2)

Baerveldt glaucoma drainage device

ACTIVE COMPARATOR
Device: Surgery/implantation

Paul glaucoma drainage device

EXPERIMENTAL
Device: Surgery/implantation

Interventions

Surgery/implantationDEVICE

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.

Baerveldt glaucoma drainage devicePaul glaucoma drainage device

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oogziekenhuis Rotterdam

Rotterdam, 3011BH, Netherlands

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Central Study Contacts

Rene J Wubbels

CONTACT

+31104023430r.wubbels@oogziekenhuis.nl

Susan Marinissen

CONTACT

+31104023449S.Marinissen@oogziekenhuis.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 25, 2022

Study Start

October 19, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 13, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)