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
3 other identifiers
interventional
200
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
August 11, 2022
CompletedFirst Posted
Study publicly available on registry
August 15, 2022
CompletedStudy Start
First participant enrolled
October 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
December 13, 2022
December 1, 2022
3.8 years
August 11, 2022
December 12, 2022
Conditions
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 (4)
ECD
Baseline, 6, 12 and 24 months
Intraocular pressure
Baseline, 1, 3, 6, 12 and 24 months
Position of the tube
Baseline, 6, 12 and 24 months
Adverse events
Time of surgery, 1, 3, 6, 12, 24 months
Study Arms (2)
GDD-tube in anterior chamber
ACTIVE COMPARATORThe 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.
GDD-tube in posterior chamber
EXPERIMENTALThe 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.
Interventions
Implantation of the GDD
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oogziekenhuis Rotterdam
Rotterdam, 3011BH, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2022
First Posted
August 15, 2022
Study Start
October 20, 2022
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
December 13, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share