Glaucoma, Open-AngleNCT04624685
iStent Inject Trabecular Micro-Bypass System Continuation Post-Approval Study
An observational study of Glaucoma, Open-Angle, run by Glaukos Corporation at 24 sites in United States.
Trial summary
Long term follow up of subjects in the IDE study for iStent Inject to monitor safety Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma, Open-Angle
- How many people
- 475 participants
- Where
- 24 sitesUnited States
- Study dates
- 15 Jan 2020to Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to 475 eyes of 475 subjects. This is based on the number of randomized subjects in the GC-008 study followed for 24 months.
Who may be able to join
- Randomized subject followed for 24 months in the GC-008 study
- Able to understand study requirements
- Willing to attend scheduled follow-up exams for 5 years post-operatively
- Able and willing to provide written informed consent on the IRB approved Informed Consent Form
Who cannot join
- None
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Keystone Research
Austin, Texas, 78731
Argus Research
Cape Coral, Florida, 33904
Chicago Eye Specialists
Chicago, Illinois, 60619
Kresge Eye Institute / Wayne State University
Detroit, Michigan, 48201
Vold Vision, PLLC
Fayetteville, Arkansas, 72704
Eye Center of northern Colorado, PC
Fort Collins, Colorado, 80528
Ophthalmology Associates
Fort Worth, Texas, 76102
Arizona Advanced Eye Research Institute
Glendale, Arizona, 85306
Discover Vision Centers
Independence, Missouri, 64055
D'Ambrosio Eye Care
Lancaster, Massachusetts, 01523
Clayton Eye Clinical Research, LLC.
Morrow, Georgia, 30260
Oklahoma eye Surgeons, PLLC
Oklahoma City, Oklahoma, 73112
Arbor Center for Eye Care
Orland Park, Illinois, 60467
Stiles Eyecare Excellence
Overland Park, Kansas, 66213
The Eye Center of Racine and Kenosha
Racine, Wisconsin, 53405
Vistar Eye Center
Roanoke, Virginia, 24016
Parkhurst Nuvision
San Antonio, Texas, 78229
R and R Eye Resarch, LLC
San Antonio, Texas, 78229
North Bath Eye Associates, Inc.
Santa Rosa, California, 95401
Glaucoma Consultants of the Capital Region
Slingerlands, New York, 12159
Northern New Jersey Eye Institute
South Orange, New Jersey, 07079
Spokane Eye Clinical Research
Spokane, Washington, 99204
International Research Center
Tampa, Florida, 33603
Center for Sight
Venice, Florida, 34285
About this study
Long term follow up of subjects in the IDE study for iStent Inject to monitor safety
Read the detailed description
To evaluate the long -term rate of clinically relevant complications associated with iStent inject® placement and stability in subjects who have completed participation of the IDE clinical trial (GC-008).
- Conditions
- Glaucoma, Open-Angle
- Medical subject headings
- Glaucoma, Open-Angle
What is being measured
The primary outcome is the main question the study is designed to answer.
iStent inject Placement and Stability
Rate of clinically relevant complications associated with iStent inject placement and stability.
Measured: 60 Months
Secondary outcomes (1)
Sight-Threatening Adverse Events
Rate of occurrence of sight-threatening adverse events
Measured: 60 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 start15 Jan 2020
- Primary completion20 Jan 2021
- Study completionDec 2021 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 475 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
- NCT04624685
- Sponsor's protocol ID
- IG2M-104-CONT
- Status last verified
- Oct 2021
- First submitted
- 5 Nov 2020
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iStent Inject Trabecular Micro-Bypass System Continuation Post-Approval Study
- ClinicalTrials.gov ID
- NCT04624685
- Acronym / sponsor ID
- IG2M-104-CONT
- Conditions
- Glaucoma, Open-Angle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 475 participants (estimated)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- Dec 2021 (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.
Long term follow up of subjects in the IDE study for iStent Inject to monitor safety
Detailed description
To evaluate the long -term rate of clinically relevant complications associated with iStent inject® placement and stability in subjects who have completed participation of the IDE clinical trial (GC-008).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 475 eyes of 475 subjects. This is based on the number of randomized subjects in the GC-008 study followed for 24 months.
Key inclusion criteria (4 listed)
- Randomized subject followed for 24 months in the GC-008 study
- Able to understand study requirements
- Willing to attend scheduled follow-up exams for 5 years post-operatively
- Able and willing to provide written informed consent on the IRB approved Informed Consent Form
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
iStent inject Placement and Stability
Time frame: 60 Months
Rate of clinically relevant complications associated with iStent inject placement and stability.
1 secondary outcome
Sight-Threatening Adverse Events
Time frame: 60 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Open-Angle, run by Glaukos Corporation at 24 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 1 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 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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: 60 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 20 Oct 2021.