GlaucomaNCT06289491
A Trial of Hydrus Microstent Versus Goniotomy
A study testing Hydrus Microstent, Incisional goniotomy and Excisional goniotomy in people with Glaucoma and Glaucoma, Open-Angle, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the comparative efficacy and safety of Hydrus Microstent, incisional goniotomy, and excisional goniotomy when combined with cataract surgery in patients with mild and moderate open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Glaucoma, Glaucoma, Open-Angle
- What is being tested?
- Hydrus Microstent, Incisional goniotomy and Excisional goniotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2025to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Visually significant cataract planned for surgery
- Mild to moderate open-angle glaucoma, including pigmentary glaucoma and pseudoexfoliation glaucoma
- Mild stage glaucoma includes glaucomatous optic neuropathy and visual field mean deviation better than -6.0 dB, with no points in the central 5 degrees <15 dB
- Moderate stage glaucoma includes: 1) glaucomatous optic neuropathy and visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5 degree points <15 dB or 2) mean deviation -12.0 dB or better with 1 central 5 degree point <15 dB
- Medicated IOP between 10 to 31 mm Hg, inclusive, at time of decision for surgery
- Willing and able to understand and provide informed consent
- Willing and able to attend postoperative examinations per protocol schedule
Who cannot join
- Prior argon laser trabeculoplasty, laser peripheral iridotomy, incisional glaucoma surgery, or cyclophotocoagulation
- Selective laser trabeculoplasty within 90 days of study enrollment
- Iridotrabecular contact for 180 degrees or greater
- Peripheral anterior synechiae in nasal or inferior angle
- Best corrected visual acuity worse than 20/200
- Phacodonesis on pre-operative examination
Show all 21Show fewer
- Vitreous in anterior chamber on pre-operative examination
- Nanophthalmos
- Anti-platelet and anticoagulant medications other than aspirin 81mg daily
- Active treatment for another ophthalmic condition in either eye (e.g., anti-VEGF injections, steroids for corneal transplant)
- Abnormality in study eye that could affect tonometry
- Glaucoma diagnosis other than the above
- Normal tension glaucoma
- Conditions that can cause elevated episcleral venous pressure (e.g., Sturge-Weber syndrome, Graves disease, retrobulbar tumor)
- History of uveitis in either eye
- Inability to complete gonioscopy examination
- Use of oral steroids within 90 days or anticipated use of oral steroids
- Oral medications that can affect IOP, including oral carbonic anhydrase inhibitors such as acetazolamide and methazolamide
- History of steroid-associated IOP elevation
- Medically unfit for attending planned study visits
- Involvement in another interventional research study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
Michael Lin, MD, 617-573-3707, michael_lin@meei.harvard.edu
Michael Lin, MD
About this study
Official title: Randomized Trial of Hydrus Microstent Versus Goniotomy
The goal of this clinical trial is to evaluate the comparative efficacy and safety of Hydrus Microstent, incisional goniotomy, and excisional goniotomy when combined with cataract surgery in patients with mild and moderate open-angle glaucoma. The main questions it aims to answer are:
- How do the intraocular pressure lowering effects of these three microinvasive glaucoma surgeries compare?
- How do the safety profiles of these three microinvasive glaucoma surgeries compare?
Participants will be randomized to one of these three microinvasive glaucoma surgeries in combination with cataract surgery.
- Conditions
- Glaucoma, Glaucoma, Open-Angle
- Being tested
- Hydrus Microstent, Incisional goniotomy, Excisional goniotomy
- Keywords
- Incisional goniotomy, Excisional goniotomy, Hydrus Microstent, Goniotomy
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrus MicrostentProcedure or surgery
Patients will have a Hydrus Microstent inserted into the canal of Schlemm at the time of cataract surgery
Incisional goniotomyProcedure or surgery
Patients will have incisional goniotomy to open the trabecular meshwork with a Sinskey hook at the time of cataract surgery
Excisional goniotomyProcedure or surgery
Patients will have excisional goniotomy to remove the trabecular meshwork with a Kahook Dual Blade at the time of cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Hydrus Microstent | Experimental | Not described Receives: Procedure: Hydrus Microstent |
| Incisional goniotomy | Experimental | Not described Receives: Procedure: Incisional goniotomy |
| Excisional goniotomy | Experimental | Not described Receives: Procedure: Excisional goniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Measured: 3 years
Intraocular pressure-lowering medications
Measured: 3 years
Secondary outcomes (1)
Surgical complications
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start14 Feb 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2029 (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
- None (open label)
- Enrolment
- 243 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael M. Lin, MD, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289491
- Sponsor's protocol ID
- 2024P000544
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Hydrus Microstent Versus Goniotomy
- ClinicalTrials.gov ID
- NCT06289491
- Acronym / sponsor ID
- 2024P000544
- Conditions
- Glaucoma, Glaucoma, Open-Angle
- Keywords
- Incisional goniotomy, Excisional goniotomy, Hydrus Microstent, Goniotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 243 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 4 Mar 2024 (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.
The goal of this clinical trial is to evaluate the comparative efficacy and safety of Hydrus Microstent, incisional goniotomy, and excisional goniotomy when combined with cataract surgery in patients with mild and moderate open-angle glaucoma. The main questions it aims to answer are:
- How do the intraocular pressure lowering effects of these three microinvasive glaucoma surgeries compare?
- How do the safety profiles of these three microinvasive glaucoma surgeries compare?
Participants will be randomized to one of these three microinvasive glaucoma surgeries in combination with cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydrus Microstent | Experimental | Procedure: Hydrus Microstent |
| Incisional goniotomy | Experimental | Procedure: Incisional goniotomy |
| Excisional goniotomy | Experimental | Procedure: Excisional goniotomy |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Visually significant cataract planned for surgery
- Mild to moderate open-angle glaucoma, including pigmentary glaucoma and pseudoexfoliation glaucoma
- Mild stage glaucoma includes glaucomatous optic neuropathy and visual field mean deviation better than -6.0 dB, with no points in the central 5 degrees <15 dB
- Moderate stage glaucoma includes: 1) glaucomatous optic neuropathy and visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5 degree points <15 dB or 2) mean deviation -12.0 dB or better with 1 central 5 degree point <15 dB
- Medicated IOP between 10 to 31 mm Hg, inclusive, at time of decision for surgery
Key exclusion criteria (21 listed)
- Prior argon laser trabeculoplasty, laser peripheral iridotomy, incisional glaucoma surgery, or cyclophotocoagulation
- Selective laser trabeculoplasty within 90 days of study enrollment
- Iridotrabecular contact for 180 degrees or greater
- Peripheral anterior synechiae in nasal or inferior angle
- Best corrected visual acuity worse than 20/200
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 |
|---|---|---|
| Hydrus MicrostentPatients will have a Hydrus Microstent inserted into the canal of Schlemm at the time of cataract surgery | Procedure or surgery | Hydrus Microstent |
| Incisional goniotomyPatients will have incisional goniotomy to open the trabecular meshwork with a Sinskey hook at the time of cataract surgery | Procedure or surgery | Incisional goniotomy |
| Excisional goniotomyPatients will have excisional goniotomy to remove the trabecular meshwork with a Kahook Dual Blade at the time of cataract surgery | Procedure or surgery | Excisional goniotomy |
Primary outcome
Intraocular pressure
Time frame: 3 years
Intraocular pressure-lowering medications
Time frame: 3 years
1 secondary outcome
Surgical complications
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrus Microstent, Incisional goniotomy and Excisional goniotomy in people with Glaucoma and Glaucoma, Open-Angle, run by Massachusetts Eye and Ear Infirmary 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 7 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 30 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael M Lin, MD (617-573-3707, michael_lin@meei.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: 3 years). 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 30 Mar 2026.