Primary Open-angle GlaucomaNCT01841437
Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry
An observational study of Primary Open-angle Glaucoma, run by Glaukos Corporation at 18 sites in United States.
Trial summary
The purpose of this study is to observe the safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild to moderate open-angle glaucoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Open-angle Glaucoma
- What is being tested?
- iStent
- Type of treatment
- Medical device
- How many people
- 191 participants
- Where
- 18 sitesUnited States
- Study dates
- Sep 2013to 21 Jun 2016
- How long will I take part?
- 36 Months
- 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: Consecutive subjects in whom implantation of the iStent is attempted at selected clinical sites
Who may be able to join
- Consecutive subjects in whom implantation of the iStent is attempted
Who cannot join
- Please refer to approved indications in Directions for Use
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Study site
Appleton, Wisconsin, 54914
Study site
Bloomington, Minnesota, 55431
Study site
Brecksville, Ohio, 44141
Study site
Chico, California, 95926
Study site
Durham, North Carolina, 27710
Study site
Fayetteville, North Carolina, 28304
Study site
Huntington Beach, California, 92647
Study site
Ladson, South Carolina, 29456
Study site
Napa, California, 94558
Study site
Parker, Colorado, 80134
Study site
Portland, Maine, 04102
Study site
Quincy, Massachusetts, 02169
Study site
Santa Maria, California, 93454
Study site
Sioux Falls, South Dakota, 57108
Study site
Southern Pines, North Carolina, 28387
Study site
Ventura, California, 93003
Study site
Westwood, New Jersey, 07675
Study site
Youngstown, Ohio, 44502
About this study
The purpose of this study is to observe the safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild to moderate open-angle glaucoma.
- Conditions
- Primary Open-angle Glaucoma
- Being tested
- iStent
- Keywords
- Primary open-angle glaucoma (POAG), Trabecular meshwork, iStent
- 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.
iStentDevice
| Study group | Role | What they receive |
|---|---|---|
| iStent | Not described Receives: Device: iStent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of sight-threatening adverse events
Measured: 36 months
Secondary outcomes (1)
Other ocular 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 posted26 Apr 2013 (estimated)
- Study startSep 2013
- Primary completion16 Feb 2016
- Study completion21 Jun 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 191 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841437
- Sponsor's protocol ID
- GTS100-PAR
- Status last verified
- Aug 2017
- First submitted
- 24 Apr 2013
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry
- ClinicalTrials.gov ID
- NCT01841437
- Acronym / sponsor ID
- GTS100-PAR
- Conditions
- Primary Open-angle Glaucoma
- Keywords
- Primary open-angle glaucoma (POAG), Trabecular meshwork, iStent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- 16 Feb 2016 (actual)
- Study completion
- 21 Jun 2016 (actual)
- First posted
- 26 Apr 2013 (estimated)
- 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 study is to observe the safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild to moderate open-angle glaucoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iStent | – | Device: iStent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive subjects in whom implantation of the iStent is attempted at selected clinical sites
Key inclusion criteria (1 listed)
- Consecutive subjects in whom implantation of the iStent is attempted
Key exclusion criteria (1 listed)
- Please refer to approved indications in Directions for Use
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 | Device | iStent |
Primary outcome
Rate of sight-threatening adverse events
Time frame: 36 months
1 secondary outcome
Other ocular adverse events
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
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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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open-angle Glaucoma, run by Glaukos Corporation at 18 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 1 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: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of sight-threatening adverse events (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 18 Dec 2017.