GlaucomaNCT04468633
The Baerveldt Versus ClearPath Comparison Study
A study testing Baerveldt 350 implant and Ahmed ClearPath 350 implant in people with Glaucoma, run by Duke University at 1 site in United States.
Trial summary
This is a randomized prospective study of post-operative surgical outcomes and complication rates in patients with a Baerveldt 350 implant vs the Ahmed ClearPath implant. Each subject will be randomized to the Baerveldt group or ClearPath group at the time of consent for the study. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Baerveldt 350 implant and Ahmed ClearPath 350 implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2020to 29 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women with age at screening ≥ 18 years and ≤ 90 years
- Inadequately controlled glaucoma
- Valve-less aqueous shunt as the planned surgical procedure
- Patients with primary glaucomas or pseudoexfoliation, pigmentary and traumatic glaucoma with a previous failed trabeculectomy or other intraocular surgery included.
- Primary tubes included
- Investigators to recruit consecutively all eligible patients from their clinics.
- Superotemporal or inferonasal placement of the tube
- Capable and willing to provide consent
Who cannot join
- NLP
- Unable/unwilling to provide informed consent
- Unavailable for regular follow up
- Previous cyclodestructive procedure
- Prior scleral buckling procedure or other external impediment to supratemporal drainage device implantation
- Presence of silicone oil
Show all 13Show fewer
- Vitreous in the anterior chamber sufficient to require a vitrectomy
- Uveitic glaucoma
- Neovascular glaucoma
- Nanophthalmos
- Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure
- Procedure combined with other surgery
- Any abnormality other than glaucoma in the study eye that could affect tonometry.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized prospective study of post-operative surgical outcomes and complication rates in patients with a Baerveldt 350 implant vs the Ahmed ClearPath implant. Each subject will be randomized to the Baerveldt group or ClearPath group at the time of consent for the study.
- Conditions
- Glaucoma
- Being tested
- Baerveldt 350 implant, Ahmed ClearPath 350 implant
- Keywords
- Baerveldt 350 implant, Ahmed ClearPath implant
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baerveldt 350 implantDevice
The Baerveldt implant is an FDA-approved silicone, non-valved implant.
Ahmed ClearPath 350 implantDevice
The Ahmed ClearPath is a non-valved glaucoma drainage device.
| Study group | Role | What they receive |
|---|---|---|
| Baerveldt 350 implant | Active comparator | Not described Receives: Device: Baerveldt 350 implant |
| Ahmed ClearPath 350 implant | Active comparator | Not described Receives: Device: Ahmed ClearPath 350 implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
Measured: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Number of Participants Who Experienced a Complication
Measured: Up to Year 1
Secondary outcomes (5)
Best Corrected Visual Acuity (BCVA)
Measured: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)
Measured: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Change in Humphrey Visual Field (HVF)
The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive value indicates an increase in visual field while a negative value indicates a decrease.
Measured: Baseline and Year 1
Change in Thickness of the Cornea as Measured by Pachymetry
Pachymetry is an ophthalmological test that measures the thickness of the cornea.
Measured: Baseline and Year 1
Change in Retinal Nerve Fiber Layer (RNFL)
The retinal nerve fiber layer (RNFL) is formed by retinal ganglion cell axons, which collect the visual impulses that begin with the rods and cones.
Measured: Baseline and Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start17 Dec 2020
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leon Herndon, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468633
- Sponsor's protocol ID
- PRO00105781
- Status last verified
- Aug 2024
- First submitted
- 9 Jul 2020
- Last updated
- 5 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Baerveldt Versus ClearPath Comparison Study
- ClinicalTrials.gov ID
- NCT04468633
- Acronym / sponsor ID
- PRO00105781
- Conditions
- Glaucoma
- Keywords
- Baerveldt 350 implant, Ahmed ClearPath implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Posted 5 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized prospective study of post-operative surgical outcomes and complication rates in patients with a Baerveldt 350 implant vs the Ahmed ClearPath implant. Each subject will be randomized to the Baerveldt group or ClearPath group at the time of consent for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baerveldt 350 implant | Active comparator | Device: Baerveldt 350 implant |
| Ahmed ClearPath 350 implant | Active comparator | Device: Ahmed ClearPath 350 implant |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women with age at screening ≥ 18 years and ≤ 90 years
- Inadequately controlled glaucoma
- Valve-less aqueous shunt as the planned surgical procedure
- Patients with primary glaucomas or pseudoexfoliation, pigmentary and traumatic glaucoma with a previous failed trabeculectomy or other intraocular surgery included.
- Primary tubes included
Key exclusion criteria (13 listed)
- NLP
- Unable/unwilling to provide informed consent
- Unavailable for regular follow up
- Previous cyclodestructive procedure
- Prior scleral buckling procedure or other external impediment to supratemporal drainage device implantation
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 |
|---|---|---|
| Baerveldt 350 implantThe Baerveldt implant is an FDA-approved silicone, non-valved implant. | Device | Baerveldt 350 implant |
| Ahmed ClearPath 350 implantThe Ahmed ClearPath is a non-valved glaucoma drainage device. | Device | Ahmed ClearPath 350 implant |
Primary outcome
Intraocular Pressure (IOP)
Time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Number of Participants Who Experienced a Complication
Time frame: Up to Year 1
5 secondary outcomes
Best Corrected Visual Acuity (BCVA)
Time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)
Time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Change in Humphrey Visual Field (HVF)
Time frame: Baseline and Year 1
Change in Thickness of the Cornea as Measured by Pachymetry
Time frame: Baseline and Year 1
Change in Retinal Nerve Fiber Layer (RNFL)
Time frame: Baseline and Year 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Leon Herndon, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baerveldt 350 implant and Ahmed ClearPath 350 implant in people with Glaucoma, run by Duke University at 1 site in United States.
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 8 inclusion and 13 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: finished, as of the sponsor's last update on 5 Sep 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (IOP) (time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1). The study lists 2 primary outcomes in all. 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 5 Sep 2024.