GlaucomaB350vsCP250NCT04542616
Baerveldt 350 vs Ahmed ClearPath 250 for the Treatment of Glaucoma
A study testing Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation in people with Glaucoma, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
To compare the safety and efficacy of Baerveldt 350 and Ahmed ClearPath 250 tube shunts in lowering IOP in glaucoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2020to 31 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Significant uncontrolled glaucoma despite medical, laser or previous surgical therapy that requires tube shunt implantation as standard-of-care to stabilize the glaucoma and preserve vision.
- Pseudophakia
- Patients who are willing to participate and are able to understand and sign the study consent form.
- Age ≥18 years.
Who cannot join
- Phakic eyes (no previous cataract surgery).
- Aphakic eyes (status post previous cataract removal but without a lens implant).
- Age <18 years.
- Women of child-bearing age.
- Patients unable to comprehend and sign the study consent form.
- Women who are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ira G. Ross Eye Institute
Buffalo, New York, 14209
About this study
Official title: Outcomes Comparison Between Baerveldt 350 and Ahmed ClearPath 250 Tube Shunts for the Treatment of Glaucoma
To compare the safety and efficacy of Baerveldt 350 and Ahmed ClearPath 250 tube shunts in lowering IOP in glaucoma patients.
Read the detailed description
Tube shunt implantation is a common type of surgery considered standard of care for treating significant potentially-blinding glaucoma where medical and laser treatment, and previous surgeries, have failed to control intra-ocular pressure (IOP) sufficiently to stop glaucoma progression towards blindness.
Since a larger plate tube (e.g., Baerveldt 350) is more difficult to implant requiring longer surgical time and intraoperative ocular muscle manipulation with possible patient discomfort, a smaller plate tube shunt (e.g., Ahmed ClearPath 250) requiring shorter surgical time and no ocular muscle manipulation may have an advantage if the long term surgical outcomes were the same.
However, the literature is lacking regarding the effect of the tube plate size on the final outcomes of tube shunt implantation. Most published comparisons are between totally different types of tube shunts regardless of plate size, often made of different materials, often comparing valved vs. non-valved tube shunts,combining different plate sizes in the same study groups,5 mixing tubes with or without combined cataract surgery in the same study groups, or comparing surgeries performed by several surgeons utilizing different surgical methods. Further, all these studies utilize tubes implanted into the anterior chamber (AC) thus increasing the risk of corneal failure, with no comparisons at all between tube shunts implanted through the ciliary sulcus of the eye designed to reduce the risk of corneal failure. Our Principle Investigator (AW) is specializing and well-published in this type of tube shunt implantation.
This prospective randomized trial is designed to resolve all these confusing factors in the literature and finally provide the answer of whether tube plate size has an effect on the final outcomes of tube shunt implantation by performing a "clean" study that would isolate the effect of tube plate size on long term outcomes. To achieve this goal our study will utilize two non-valved tube shunts with a different plate size (350 vs. 250 mm2) made of identical materials, in eyes that have already had cataract surgery, and all performed by the same surgeon (AW) through the ciliary sulcus.
- Conditions
- Glaucoma
- Being tested
- Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation
- Keywords
- Glaucoma, Baerveldt 350, Ahmed ClearPath 250
- 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 vs. Ahmed ClearPath 250 tube shunt implantationDevice
Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation for the treatment of severe uncontrolled glaucoma.
| Study group | Role | What they receive |
|---|---|---|
| Baerveldt 350 | Active comparator | The patients in this arm will receive a Baerveldt 350 tube shunt implantation for the treatment of their severe uncontrolled glaucoma. Receives: Device: Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation |
| Ahmed ClearPath 250 | Active comparator | The patients in this arm will receive an Ahmed ClearPath 250 tube shunt implantation for the treatment of their severe uncontrolled glaucoma. Receives: Device: Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
Mean IOP in each treatment group at the above time points
Measured: Baseline, Month 1, Month 3, Month 6, Month 12, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start13 Aug 2020
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
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 State University of New York at BuffaloThe 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
- Model description
- Comparison between 2 groups of patients requiring tube shunt implantation to treat their severe uncontrolled glaucoma. One group will receive a unilateral Baerveldt 350 tube shunt and the other a unilateral Ahmed ClearPath 250 tube shunt. The patients will be sequentially randomized into one of these tube shunts.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asher Weiner, MD, State University of New York at Buffalo
- Investigators
- Asher Weiner, MD, Principal investigator, The Ross Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542616
- Sponsor's protocol ID
- STUDY00004680
- Acronym
- B350vsCP250
- Status last verified
- Jan 2025
- First submitted
- 27 Aug 2020
- Last updated
- 17 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Comparison Between Baerveldt 350 and Ahmed ClearPath 250 Tube Shunts for the Treatment of Glaucoma
- ClinicalTrials.gov ID
- NCT04542616
- Acronym / sponsor ID
- B350vsCP250 / STUDY00004680
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Baerveldt 350, Ahmed ClearPath 250
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Posted 17 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety and efficacy of Baerveldt 350 and Ahmed ClearPath 250 tube shunts in lowering IOP in glaucoma patients.
Detailed description
Tube shunt implantation is a common type of surgery considered standard of care for treating significant potentially-blinding glaucoma where medical and laser treatment, and previous surgeries, have failed to control intra-ocular pressure (IOP) sufficiently to stop glaucoma progression towards blindness.
Since a larger plate tube (e.g., Baerveldt 350) is more difficult to implant requiring longer surgical time and intraoperative ocular muscle manipulation with possible patient discomfort, a smaller plate tube shunt (e.g., Ahmed ClearPath 250) requiring shorter surgical time and no ocular muscle manipulation may have an advantage if the long term surgical outcomes were the same.
However, the literature is lacking regarding the effect of the tube plate size on the final outcomes of tube shunt implantation. Most published comparisons are between totally different types of tube shunts regardless of plate size, often made of different materials, often comparing valved vs. non-valved tube shunts,combining different plate sizes in the same study groups,5 mixing tubes with or without combined cataract surgery in the same study groups, or comparing surgeries performed by several surgeons utilizing different surgical methods. Further, all these studies utilize tubes implanted into the anterior chamber (AC) thus increasing the risk of corneal failure, with no comparisons at all between tube shunts implanted through the ciliary sulcus of the eye designed to reduce the risk of corneal failure. Our Principle Investigator (AW) is specializing and well-published in this type of tube shunt implantation.
This prospective randomized trial is designed to resolve all these confusing factors in the literature and finally provide the answer of whether tube plate size has an effect on the final outcomes of tube shunt implantation by performing a "clean" study that would isolate the effect of tube plate size on long term outcomes. To achieve this goal our study will utilize two non-valved tube shunts with a different plate size (350 vs. 250 mm2) made of identical materials, in eyes that have already had cataract surgery, and all performed by the same surgeon (AW) through the ciliary sulcus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Comparison between 2 groups of patients requiring tube shunt implantation to treat their severe uncontrolled glaucoma. One group will receive a unilateral Baerveldt 350 tube shunt and the other a unilateral Ahmed ClearPath 250 tube shunt. The patients will be sequentially randomized into one of these tube shunts.
| Arm | Type | Receives |
|---|---|---|
| Baerveldt 350 | Active comparator | Device: Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantationThe patients in this arm will receive a Baerveldt 350 tube shunt implantation for the treatment of their severe uncontrolled glaucoma. |
| Ahmed ClearPath 250 | Active comparator | Device: Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantationThe patients in this arm will receive an Ahmed ClearPath 250 tube shunt implantation for the treatment of their severe uncontrolled glaucoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Significant uncontrolled glaucoma despite medical, laser or previous surgical therapy that requires tube shunt implantation as standard-of-care to stabilize the glaucoma and preserve vision.
- Pseudophakia
- Patients who are willing to participate and are able to understand and sign the study consent form.
- Age ≥18 years.
Key exclusion criteria (6 listed)
- Phakic eyes (no previous cataract surgery).
- Aphakic eyes (status post previous cataract removal but without a lens implant).
- Age <18 years.
- Women of child-bearing age.
- Patients unable to comprehend and sign the study consent form.
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 vs. Ahmed ClearPath 250 tube shunt implantationBaerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation for the treatment of severe uncontrolled glaucoma. | Device | Ahmed ClearPath 250, Baerveldt 350 |
Primary outcome
Intraocular Pressure (IOP)
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, Month 24
Mean IOP in each treatment group at the above time points
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Asher Weiner, MD principal investigator
The Ross Eye Institute
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 vs. Ahmed ClearPath 250 tube shunt implantation in people with Glaucoma, run by State University of New York at Buffalo 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 4 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: finished, as of the sponsor's last update on 17 Apr 2026. 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 17 Apr 2026). 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, Month 1, Month 3, Month 6, Month 12, Month 24). 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 17 Apr 2026.