Open-angle GlaucomaSUMMITNCT03267134
Hydrus Microstent for Refractory Open-Angle Glaucoma
A study testing Hydrus Microstent and Ophthalmic surgery in people with Open-angle Glaucoma, run by Ivantis, Inc. at 20 sites in 5 countries.
Trial summary
The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent in patients with refractory open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Open-angle Glaucoma
- What is being tested?
- Hydrus Microstent and Ophthalmic surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 1 Aug 2017to 16 Dec 2022
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Open-angle glaucoma with optic nerve pathology;
- BCVA of 20/80 or better in study eye;
- Refractory glaucoma;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Secondary glaucoma other than pseudoexfoliative and pigmentary glaucoma;
- Acute angle closure, chronic angle closure, or congenial, malignant, or developmental glaucoma;
- Pre-perimetric glaucoma;
- Ocular hypertension
- Shallow or flat anterior chamber;
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
United States16 sites
Louisiana Eye and Laser Center
Alexandria, Louisiana, 71303
Texan Eye
Austin, Texas, 78731
Scott & Christie and Associates
Cranberry Township, Pennsylvania, 16066
Glaucoma Associates of Texas
Dallas, Texas, 75231
El Paso Eye Surgeons
El Paso, Texas, 79902
Vold Vision
Fayetteville, Arkansas, 72704
Eye Center of Northern Colorado
Fort Collins, Colorado, 80528
Ophthalmology Associates
Fort Worth, Texas, 76102
Vale-Asche Russell Clinical Research Center
Houston, Texas, 77030
The Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, 53142
Ocala Eye
Ocala, Florida, 34474
Stiles Eyecare
Overland Park, Kansas, 66213
Sacramento Eye Consultants
Sacramento, California, 95815
R and R Research, LLC
San Antonio, Texas, 78229
Washington University in St. Louis Ophthalmology
St Louis, Missouri, 63110
Center for Sight
Venice, Florida, 34283
About this study
Official title: The Hydrus Microstent for Refractory Open-Angle Glaucoma: A Prospective, Multicenter Clinical Trial (Hydrus VII Study)
The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent in patients with refractory open-angle glaucoma.
Read the detailed description
Participants will attend a screening visit, a baseline visit, a surgery visit, and 8 post-operative visits (Day 1, Day 7, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12), for a total individual duration of approximately 14 months.
- Conditions
- Open-angle Glaucoma
- Being tested
- Hydrus Microstent, Ophthalmic surgery
- Keywords
- Glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrus MicrostentDevice
Device implanted into the Schlemm's canal of the eye to provide a natural outflow pathway for aqueous humor, leading to a reduction in intraocular pressure (IOP). The Hydrus Microstent is intended for lifetime use of the glaucoma patient.
Ophthalmic surgeryProcedure or surgery
Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Hydrus Microstent | Experimental | Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training. Only one eye (study eye) will be implanted. Receives: Device: Hydrus Microstent; Procedure: Ophthalmic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline
Intraocular pressure was measured using Goldmann Applanation tonometry. Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure.
Measured: Baseline, Month 12
Secondary outcomes (1)
Mean Change From Baseline in MDIOP at Month 12
Intraocular pressure was measured using Goldmann Applanation tonometry and recorded in millimeters mercury (mmHG). Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure. A negative number represents a reduction from baseline. For non-responders, data was imputed as specified in the protocol. No hypothesis testing was pre-specified for this outcome measure.
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Aug 2017
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
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 Open-angle 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivantis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Project Lead, CRD Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267134
- Sponsor's protocol ID
- CP 16-001
- Acronym
- SUMMIT
- Status last verified
- Dec 2025
- First submitted
- 22 Aug 2017
- Last updated
- 14 Jan 2026
- 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hydrus Microstent for Refractory Open-Angle Glaucoma: A Prospective, Multicenter Clinical Trial (Hydrus VII Study)
- ClinicalTrials.gov ID
- NCT03267134
- Acronym / sponsor ID
- SUMMIT / CP 16-001
- Conditions
- Open-angle Glaucoma
- Keywords
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Ivantis, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Posted 14 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent in patients with refractory open-angle glaucoma.
Detailed description
Participants will attend a screening visit, a baseline visit, a surgery visit, and 8 post-operative visits (Day 1, Day 7, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12), for a total individual duration of approximately 14 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydrus Microstent | Experimental | Device: Hydrus Microstent, Procedure: Ophthalmic surgeryHydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training. Only one eye (study eye) will be implanted. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Open-angle glaucoma with optic nerve pathology;
- BCVA of 20/80 or better in study eye;
- Refractory glaucoma;
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (6 listed)
- Secondary glaucoma other than pseudoexfoliative and pigmentary glaucoma;
- Acute angle closure, chronic angle closure, or congenial, malignant, or developmental glaucoma;
- Pre-perimetric glaucoma;
- Ocular hypertension
- Shallow or flat anterior chamber;
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 MicrostentDevice implanted into the Schlemm's canal of the eye to provide a natural outflow pathway for aqueous humor, leading to a reduction in intraocular pressure (IOP). The Hydrus Microstent is intended for lifetime use of the glaucoma patient. | Device | Hydrus Microstent |
| Ophthalmic surgeryImplantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia | Procedure or surgery | Hydrus Microstent |
Primary outcome
Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline
Time frame: Baseline, Month 12
Intraocular pressure was measured using Goldmann Applanation tonometry. Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure.
1 secondary outcome
Mean Change From Baseline in MDIOP at Month 12
Time frame: Baseline, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- 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.
Clinical Project Lead, CRD Surgical study director
Alcon Research, LLC
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrus Microstent and Ophthalmic surgery in people with Open-angle Glaucoma, run by Ivantis, Inc. at 20 sites in 5 countries.
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 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Colombia, Philippines, Spain, United Kingdom. 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 14 Jan 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?
Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline (time frame: Baseline, Month 12). 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 14 Jan 2026.