Glaucoma, Open-AngleNCT04624698
iStent Inject New Enrollment Post-Approval Study
A study testing iStent Inject Implantation in people with Glaucoma, Open-Angle and Glaucoma, run by Glaukos Corporation at 3 sites in United States.
Trial summary
Study to evaluate the rate of clinically relevant complications associated with iStent inject placement in the post-market setting. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Glaucoma
- What is being tested?
- iStent Inject Implantation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Sep 2020to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 22 years of age
- Mild to moderate primary open-angle glaucoma
- Scheduled to undergo cataract surgery
- Able and willing to attend scheduled follow-up exams for three years postoperatively
- Able and willing to provide written informed consent on the IRB approved Informed Consent Form
- Operative Inclusion Criterion:
- Successful, uncomplicated cataract surgery
Who cannot join
- Angle closure glaucoma
- Traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
- Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Glaucoma Associates of Texas
Dallas, Texas, 75231
Eye Doctors of Arizona, PLLC
Phoenix, Arizona, 85003
Wolstan and Goldberg Eye Associates
Torrance, California, 90505
About this study
Official title: iStent Inject Trabecular Micro-Bypass System New Enrollment Post-Approval Study
Study to evaluate the rate of clinically relevant complications associated with iStent inject placement in the post-market setting.
Read the detailed description
To evaluate the rate of clinically relevant complications associated with iStent inject placement and stability, as determined at 36 months in the postmarket setting.
- Conditions
- Glaucoma, Open-Angle, Glaucoma
- Being tested
- iStent Inject Implantation
- 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.
iStent Inject ImplantationDevice
Subjects will be implanted with the iStent Injection Micro-Bypass device
| Study group | Role | What they receive |
|---|---|---|
| Implantation | Experimental | Subjects will undergo cataract surgery and then implantation of the iStent Inject trabecular micro-bypass device. Receives: Device: iStent Inject Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
iStent inject placement and stability
The rate of clinically relevant complications associated with iStent inject placement and stability
Measured: 36 Months
Secondary outcomes (1)
Sight-threatening adverse events
Rate of occurrence of sight-threatening adverse events
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start22 Sep 2020
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624698
- Sponsor's protocol ID
- IG2M-105-PASN
- Status last verified
- Feb 2024
- First submitted
- 5 Nov 2020
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iStent Inject Trabecular Micro-Bypass System New Enrollment Post-Approval Study
- ClinicalTrials.gov ID
- NCT04624698
- Acronym / sponsor ID
- IG2M-105-PASN
- Conditions
- Glaucoma, Open-Angle, Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 12 Nov 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.
Study to evaluate the rate of clinically relevant complications associated with iStent inject placement in the post-market setting.
Detailed description
To evaluate the rate of clinically relevant complications associated with iStent inject placement and stability, as determined at 36 months in the postmarket setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation | Experimental | Device: iStent Inject ImplantationSubjects will undergo cataract surgery and then implantation of the iStent Inject trabecular micro-bypass device. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female ≥ 22 years of age
- Mild to moderate primary open-angle glaucoma
- Scheduled to undergo cataract surgery
- Able and willing to attend scheduled follow-up exams for three years postoperatively
- Able and willing to provide written informed consent on the IRB approved Informed Consent Form
Key exclusion criteria (3 listed)
- Angle closure glaucoma
- Traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
- Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure
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 |
|---|---|---|
| iStent Inject ImplantationSubjects will be implanted with the iStent Injection Micro-Bypass device | Device | Implantation |
Primary outcome
iStent inject placement and stability
Time frame: 36 Months
The rate of clinically relevant complications associated with iStent inject placement and stability
1 secondary outcome
Sight-threatening adverse events
Time frame: 36 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Glaucoma, Open-Angle
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Recruiting
A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma
Glaucoma
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iStent Inject Implantation in people with Glaucoma, Open-Angle and Glaucoma, run by Glaukos Corporation at 3 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
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?
iStent inject placement and stability (time frame: 36 Months). 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 23 Feb 2024.