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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

NCT ID: NCT05500469

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-20

Study Completion Date

2026-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Paul glaucoma drainage device (GDD)

Intervention Type DEVICE

Implantation of the GDD

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.

Group Type EXPERIMENTAL

Paul glaucoma drainage device (GDD)

Intervention Type DEVICE

Implantation of the GDD

Interventions

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Paul glaucoma drainage device (GDD)

Implantation of the GDD

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oogziekenhuis Rotterdam

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oogziekenhuis Rotterdam

Rotterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Rene Wubbels

Role: CONTACT

Phone: +31104023430

Email: [email protected]

Susan Marinissen

Role: CONTACT

Phone: +31104023449

Email: [email protected]

Facility Contacts

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Rene J Wubbels, PhD

Role: primary

Ionela Popescu-Giovanitsas, MD

Role: backup

Other Identifiers

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NL81305.078.22

Identifier Type: OTHER

Identifier Source: secondary_id

MEC-2022-0364

Identifier Type: OTHER

Identifier Source: secondary_id

OZR-2022-03

Identifier Type: -

Identifier Source: org_study_id