GlaucomaNCT05344651
Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium
A study testing Surgery/implantation in people with Glaucoma, run by Oogziekenhuis Rotterdam at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Surgery/implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Oct 2022to Jun 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.
- 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.
Who cannot join
- 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.
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: 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.
Read more
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.
- Conditions
- Glaucoma
- Being tested
- Surgery/implantation
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Baerveldt glaucoma drainage device | Active comparator | Not described Receives: Device: Surgery/implantation |
| Paul glaucoma drainage device | Experimental | Not described Receives: Device: Surgery/implantation |
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 (3)
Endothelial cell density (ECD).
ECD will be assessed at the center of the cornea and close to the tube.
Measured: Baseline, 3, 6, 12, 24 months.
Intraocular pressure.
Intraocular pressure.
Measured: Baseline, 1, 3, 6, 12, 24 months.
Orthoptic assessment.
Prism cover test: total deviation at 30 cm; Goldmann: monocular ductions in 8 directions starting from primary position, binocular field of single vision.
Measured: Baseline, 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 posted25 Apr 2022
- Study start19 Oct 2022
- Primary completionJun 2026 (estimated)
- Study completionJun 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 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
- NCT05344651
- Sponsor's protocol ID
- OZR-2020-30
- Other IDs
- NL80518.078.22, MEC-2022-0069
- Status last verified
- Dec 2022
- First submitted
- 19 Apr 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
- Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium
- ClinicalTrials.gov ID
- NCT05344651
- Acronym / sponsor ID
- OZR-2020-30
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Oogziekenhuis RotterdamUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 25 Apr 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: 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baerveldt glaucoma drainage device | Active comparator | Device: Surgery/implantation |
| Paul glaucoma drainage device | Experimental | Device: Surgery/implantation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Surgery/implantationThe 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. | Device | Baerveldt glaucoma drainage device, Paul glaucoma drainage device |
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.
3 secondary outcomes
Endothelial cell density (ECD).
Time frame: Baseline, 3, 6, 12, 24 months.
Intraocular pressure.
Time frame: Baseline, 1, 3, 6, 12, 24 months.
Orthoptic assessment.
Time frame: Baseline, 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 Surgery/implantation 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 4 inclusion and 8 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 J 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.