GlaucomaNCT05500469
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
A study testing Paul glaucoma drainage device (GDD) in people with Glaucoma, run by Oogziekenhuis Rotterdam at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Paul glaucoma drainage device (GDD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Oct 2022to Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Oogziekenhuis Rotterdam
Rotterdam, 3011BH
Rene J Wubbels, PhD, +31104023430, r.wubbels@oogziekenhuis.nl
Ionela Popescu-Giovanitsas, MD, +31104023447, I.Popescu@oogziekenhuis.nl
About this study
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.
Read more
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).
- Conditions
- Glaucoma
- Being tested
- Paul glaucoma drainage device (GDD)
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paul glaucoma drainage device (GDD)Device
Implantation of the GDD
| Study group | Role | What they receive |
|---|---|---|
| GDD-tube in anterior chamber | Active comparator | 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. Receives: Device: Paul glaucoma drainage device (GDD) |
| GDD-tube in posterior chamber | Experimental | 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. Receives: Device: Paul glaucoma drainage device (GDD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of endothelial cell density (ECD)
ECD will be assessed at the center of the cornea and close to the tube
Measured: Baseline and 2 years
Secondary outcomes (4)
ECD
ECD will be assessed at the center of the cornea and close to the tube
Measured: Baseline, 6, 12 and 24 months
Intraocular pressure
Intraocular pressure
Measured: Baseline, 1, 3, 6, 12 and 24 months
Position of the tube
Position of the tube on anterior segment OCT
Measured: Baseline, 6, 12 and 24 months
Adverse events
Complications at the time of surgery, postoperative adverse events
Measured: Time of surgery, 1, 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start20 Oct 2022
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oogziekenhuis Rotterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500469
- Sponsor's protocol ID
- OZR-2022-03
- Other IDs
- NL81305.078.22, MEC-2022-0364
- Status last verified
- Dec 2022
- First submitted
- 11 Aug 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05500469
- Acronym / sponsor ID
- OZR-2022-03
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oogziekenhuis RotterdamUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDD-tube in anterior chamber | Active comparator | Device: Paul glaucoma drainage device (GDD)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. |
| GDD-tube in posterior chamber | Experimental | Device: Paul glaucoma drainage device (GDD)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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paul glaucoma drainage device (GDD)Implantation of the GDD | Device | GDD-tube in anterior chamber, GDD-tube in posterior chamber |
Primary outcome
Change of endothelial cell density (ECD)
Time frame: Baseline and 2 years
ECD will be assessed at the center of the cornea and close to the tube
4 secondary outcomes
ECD
Time frame: Baseline, 6, 12 and 24 months
Intraocular pressure
Time frame: Baseline, 1, 3, 6, 12 and 24 months
Position of the tube
Time frame: Baseline, 6, 12 and 24 months
Adverse events
Time frame: Time of surgery, 1, 3, 6, 12, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paul glaucoma drainage device (GDD) in people with Glaucoma, run by Oogziekenhuis Rotterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rene Wubbels (+31104023430, r.wubbels@oogziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of endothelial cell density (ECD) (time frame: Baseline and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.