Primary Open Angle GlaucomaCONFIRMNCT04553523
Hydrus® Microstent New Enrollment Post-Approval Study
A study testing Hydrus Microstent, Cataract surgery and Monofocal IOL in people with Primary Open Angle Glaucoma, run by Alcon Research at 22 sites in United States.
Trial summary
The purpose of this post-approval study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- Hydrus Microstent, Cataract surgery and Monofocal IOL
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 545 participants
- Where
- 22 sitesUnited States
- Study dates
- 25 Aug 2020to Oct 2028
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An operable, age-related cataract with best corrected visual acuity (BCVA) of 20/40 or worse;
- Diagnosis of primary open angle glaucoma treated with no more than 4 topical hypotensive medications;
- Optic nerve appearance characteristic of glaucoma;
- Medicated IOP less than or equal to 31 millimeters mercury (mmHg); Other protocol-defined inclusion criteria may apply.
Who cannot join
- Closed angle forms of glaucoma;
- Congenital or developmental glaucoma;
- Secondary glaucoma;
- Use of more than 4 ocular hypotensive medications;
- Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative surgery;
- Prior surgery with implanted device or other surgery involving the trabecular meshwork or Schlemm's canal;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 20 recruiting
- Recruiting
Texan Eye / Keystone Research
Austin, Texas, 78731
- Completed
Cleveland Eye Clinic
Brecksville, Ohio, 44141
- Recruiting
Midwest Vision Research Foundation
Chesterfield, Missouri, 63017
- Recruiting
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
- Recruiting
Twin Cities Eye Consultants
Coon Rapids, Minnesota, 55433
- Not yet recruiting
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
- Not yet recruiting
Glaucoma Associates Of Texas
Dallas, Texas, 75231
- Recruiting
El Paso Eye Surgeons
El Paso, Texas, 79902
- Recruiting
Fraser Eye Care Center
Fraser, Michigan, 48026
- Recruiting
Texas Eye Research Center
Hurst, Texas, 76054
- Completed
Coastal Vision
Irvine, California, 92618
- Not yet recruiting
Moyes Eye Center
Kansas City, Missouri, 64154
- Recruiting
Eye Centers Of Racine And Kenosha
Kenosha, Wisconsin, 53142
- Recruiting
Center for Sight
Las Vegas, Nevada, 89145
- Recruiting
Eye Center of Northern Colorado
Loveland, Colorado, 80538
- Not yet recruiting
Cincinnati Eye / Apex Eye
Mason, Ohio, 45040
- Not yet recruiting
Stiles Eyecare Excellence Cataracts and Glaucoma
Overland Park, Kansas, 66213
- Not yet recruiting
Visionary Eye Doctors
Rockville, Maryland, 20852
- Recruiting
Sacramento Eye Consultants
Sacramento, California, 95815
- Not yet recruiting
The Eye Institute of Utah
Salt Lake City, Utah, 84107
- Recruiting
Jones Eye Center PC
Sioux City, Iowa, 51104
- Recruiting
Carolina Eye Associates PA
Southern Pines, North Carolina, 28387
About this study
Official title: The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial
The purpose of this post-approval study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.
Read the detailed description
Qualified subjects will attend a screening visit, a surgical visit (Day 0), and 8 scheduled postoperative visits at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24.
This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Hydrus Microstent, Cataract surgery, Monofocal IOL
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrus MicrostentDevice
Crescent-shaped nitinol device intended as a permanent implant to provide an outflow pathway for aqueous humor. The device is placed through the trabecular meshwork into Schlemm's canal immediately following placement of a monofocal IOL.
Cataract surgeryProcedure or surgery
Cataract surgery performed using standard anesthesia and phacoemulsification techniques
Monofocal IOLDevice
Commercially available monofocal intraocular lens as determined by the investigator
| Study group | Role | What they receive |
|---|---|---|
| Hydrus Microstent | Experimental | Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL) Receives: Device: Hydrus Microstent; Procedure: Cataract surgery; Device: Monofocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of occurrence of clinically significant device malposition associated with clinical sequelae
The position of the implant will be assessed visually intraoperatively and at each postoperative follow-up visit. Examples of clinically significant device malposition associated with clinical sequelae as listed in the protocol include secondary surgical intervention to modify device position or to remove the device (explantation), corneal endothelial touch by device, iris touch by the device associated with intraocular inflammation, pigment dispersion or other sequelae, central endothelial cell loss ≥30 percent, compromised corneal function, best-corrected visual acuity (BCVA) loss of 2 lines (10 letters) or more on the ETDRS chart, device obstruction requiring secondary surgical intervention, persistent anterior chamber inflammation with peripheral anterior synechiae, persistent anterior chamber inflammation without peripheral anterior synechiae, and chronic pain.
Measured: Day 0 operative, up to Month 24 postoperative
Secondary outcomes (3)
Rate of occurrence of intraoperative ocular adverse events
Intraoperative ocular adverse events as specified in the protocol include hyphema obscuring the surgeon's view, choroidal hemorrhage or effusion, choroidal detachment, significant iris injury or trauma, corneal abrasion, corneal edema, zonular dialysis, cyclodialysis, cyclodialysis cleft, iridodialysis, vitreous loss not associated with the cataract procedure, inadvertent perforation of the sclera, and Descemet's membrane detachment.
Measured: Day 0 operative
Rate of occurrence of sight threatening postoperative adverse events
Sight threatening, post-operative adverse events as specified in the protocol include endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment, and aqueous misdirection.
Measured: Up to Month 24
Rate of occurrence of other postoperative ocular adverse events
Other postoperative ocular adverse events as specified in the protocol include anterior uveitis/iritis, non-persistent \& persistent, best corrected visual acuity (BCVA) loss of 2 lines or more, chronic pain, device migration, device obstruction, peripheral anterior synechiae (PAS), ocular secondary surgical interventions for intraocular pressure (IOP) or glaucoma management, hypotony at or after 1 month postop, hyphema, corneal opacification, corneal edema persisting or severe corneal edema, other retinal complications, elevated mean IOP >/=10 millimeters mercury (mmHg) vs screening, iris prolapse/wound incarceration, significant foreign body sensation at or after 3 months postop, surgical re-intervention, and worsening of visual field.
Measured: Up to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start25 Aug 2020
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- 545 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Project Lead, CDMA Surgical, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553523
- Sponsor's protocol ID
- CP 18-001
- Other IDs
- GLI314-C003
- Acronym
- CONFIRM
- Status last verified
- Jul 2026
- First submitted
- 11 Sep 2020
- Last updated
- 22 Sep 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial
- ClinicalTrials.gov ID
- NCT04553523
- Acronym / sponsor ID
- CONFIRM / CP 18-001
- Conditions
- Primary Open Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 545 participants (estimated)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 17 Sep 2020 (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 purpose of this post-approval study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.
Detailed description
Qualified subjects will attend a screening visit, a surgical visit (Day 0), and 8 scheduled postoperative visits at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24.
This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.
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: Cataract surgery, Device: Monofocal IOLHydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- An operable, age-related cataract with best corrected visual acuity (BCVA) of 20/40 or worse;
- Diagnosis of primary open angle glaucoma treated with no more than 4 topical hypotensive medications;
- Optic nerve appearance characteristic of glaucoma;
- Medicated IOP less than or equal to 31 millimeters mercury (mmHg); Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (7 listed)
- Closed angle forms of glaucoma;
- Congenital or developmental glaucoma;
- Secondary glaucoma;
- Use of more than 4 ocular hypotensive medications;
- Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative 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 |
|---|---|---|
| Hydrus MicrostentCrescent-shaped nitinol device intended as a permanent implant to provide an outflow pathway for aqueous humor. The device is placed through the trabecular meshwork into Schlemm's canal immediately following placement of a monofocal IOL. | Device | Hydrus Microstent |
| Cataract surgeryCataract surgery performed using standard anesthesia and phacoemulsification techniques | Procedure or surgery | Hydrus Microstent |
| Monofocal IOLCommercially available monofocal intraocular lens as determined by the investigator | Device | Hydrus Microstent |
Primary outcome
Rate of occurrence of clinically significant device malposition associated with clinical sequelae
Time frame: Day 0 operative, up to Month 24 postoperative
The position of the implant will be assessed visually intraoperatively and at each postoperative follow-up visit. Examples of clinically significant device malposition associated with clinical sequelae as listed in the protocol include secondary surgical intervention to modify device position or to remove the device (explantation), corneal endothelial touch by device, iris touch by the device associated with intraocular inflammation, pigment dispersion or other sequelae, central endothelial cell loss ≥30 percent, compromised corneal function, best-corrected visual acuity (BCVA) loss of 2 lines (10 letters) or more on the ETDRS chart, device obstruction requiring secondary surgical intervention, persistent anterior chamber inflammation with peripheral anterior synechiae, persistent anterior chamber inflammation without peripheral anterior synechiae, and chronic pain.
3 secondary outcomes
Rate of occurrence of intraoperative ocular adverse events
Time frame: Day 0 operative
Rate of occurrence of sight threatening postoperative adverse events
Time frame: Up to Month 24
Rate of occurrence of other postoperative ocular adverse events
Time frame: Up to Month 24
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 22 Sep 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.
Clinical Project Lead, CDMA Surgical study director
Alcon Research
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrus Microstent, Cataract surgery and Monofocal IOL in people with Primary Open Angle Glaucoma, run by Alcon Research at 22 sites 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 7 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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 Alcon Call Center (1-888-451-3937, alcon.medinfo@alcon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of occurrence of clinically significant device malposition associated with clinical sequelae (time frame: Day 0 operative, up to Month 24 postoperative). 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 22 Sep 2026.