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

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).

Study Overview

• Status: Recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Device: Paul glaucoma drainage device (GDD)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Marinissen; Phone Number: +31104023449; Email: S.Marinissen@oogziekenhuis.nl
• Study Contact Backup: Name: Rene Wubbels; Phone Number: +31104023430; Email: r.wubbels@oogziekenhuis.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3011BH
    • Recruiting
    • Oogziekenhuis Rotterdam
    • Contact: Rene J Wubbels, PhD; Phone Number: +31104023430; Email: r.wubbels@oogziekenhuis.nl
    • Contact: Ionela Popescu-Giovanitsas, MD; Phone Number: +31104023447; Email: I.Popescu@oogziekenhuis.nl
    • Principal Investigator: Peter de Waard, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GDD-tube in anterior chamber; The Paul 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 or nasal quadrant of the eye. The tube is positioned in the anterior chamber.	Device: Paul glaucoma drainage device (GDD); Implantation of the GDD
Experimental: GDD-tube in posterior chamber; The Paul 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 or nasal quadrant of the eye. The tube is positioned in the posterior chamber.	Device: Paul glaucoma drainage device (GDD); Implantation of the GDD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECD	ECD will be assessed at the center of the cornea and close to the tube	Baseline, 6, 12 and 24 months
Intraocular pressure	Intraocular pressure	Baseline, 1, 3, 6, 12 and 24 months
Position of the tube	Position of the tube on anterior segment OCT	Baseline, 6, 12 and 24 months
Adverse events	Complications at the time of surgery, postoperative adverse events	Time of surgery, 1, 3, 6, 12, 24 months

Collaborators and Investigators

• Sponsor: Oogziekenhuis Rotterdam

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Anticipated): August 1, 2026
• Study Completion (Anticipated): August 1, 2026

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: OZR-2022-03; NL81305.078.22 (Other Identifier: CCMO); MEC-2022-0364 (Other Identifier: MEC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No