Primary Open Angle GlaucomaNCT01836042

Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent: Extended Follow-up of the Premarket Cohort

An observational study of Primary Open Angle Glaucoma, run by Glaukos Corporation at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos Study GC-003. Read more about this study

Who is it for?: Any age
Conditions the study is for: Primary Open Angle Glaucoma
How many people: 108 participants
Where: 26 sitesUnited States
Study dates: Jul 2013to Apr 2014
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Extended follow-up of subjects previously enrolled in Glaukos Study GC-003

Who may be able to join

Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to participate in this extended follow-up study

Who cannot join

Subjects previously enrolled in Glaukos Study GC-003 who are not able or willing to participate in this extended follow-up study
Patients not previously enrolled in Glaukos Study GC-003

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Study site
Baton Rouge, Louisiana, 70806
Study site
Beaumont, Texas, 77702
Study site
Beverly Hills, California, 90210
Study site
Bloomington, Minnesota, 55431
Study site
Boynton Beach, Florida, 33426
Study site
Brookville, Pennsylvania, 15825
Study site
Cincinnati, Ohio, 45242
Study site
Edina, Minnesota, 55435
Study site
Independence, Missouri, 64055
Study site
Indianapolis, Indiana, 46260
Study site
Kansas City, Missouri, 64133
Study site
Las Vegas, Nevada, 89121
Study site
Louisville, Kentucky, 40206
Study site
Miami, Florida, 33176
Study site
Morrow, Georgia, 30260
Study site
Overland Park, Kansas, 66213
Study site
Parker, Colorado, 80134
Study site
Petaluma, California, 94954
Study site
Philadelphia, Pennsylvania, 19107
Study site
Pittsburgh, Pennsylvania, 15122
Study site
Sacramento, California, 95817
Study site
Saint Joseph, Michigan, 49085
Study site
San Clemente, California, 92673
Study site
Santa Maria, California, 93454
Study site
Tampa, Florida, 33603
Study site
Winston-Salem, North Carolina, 27101

Other trials in United States

About this study

Official title: Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent System In Conjunction With Cataract Surgery: Extended Follow-up of the Premarket Cohort

The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos Study GC-003.

Read the detailed description

The goal of this study was to demonstrate that use of this device in conjunction with cataract surgery did not result in a rate of sight-threatening adverse events, after 5 years of implantation that was higher than the rate of sight-threatening adverse events that occurred after cataract surgery alone, by more than a non-inferiority margin of 5%.

Conditions: Primary Open Angle Glaucoma
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.

Study groups in NCT01836042
Study group	Role	What they receive
Randomized iStent		Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
Randomized cataract surgery		Cataract surgery alone, patients randomized to group
Non-randomized iStent		Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Sight-threatening Adverse Events
The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group.
Measured: 80 Month average

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Apr 2014

First posted19 Apr 2013 (estimated)
Study startJul 2013
Primary completionApr 2014
Study completionApr 2014

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 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: Retrospective
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01836042
Sponsor's protocol ID: GTS100-PAS
Status last verified: Mar 2016
First submitted: 17 Apr 2013
Last updated: 15 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Primary Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent System In Conjunction With Cataract Surgery: Extended Follow-up of the Premarket Cohort
ClinicalTrials.gov ID: NCT01836042
Acronym / sponsor ID: GTS100-PAS
Conditions: Primary Open Angle Glaucoma
Keywords: Primary open-angle glaucoma (POAG), Trabecular meshwork, iStent
Study type: Observational
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Glaukos CorporationIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 19 Apr 2013 (estimated)
Results: Posted 15 Apr 2016

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 long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos Study GC-003.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
Randomized iStent	–	–Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
Randomized cataract surgery	–	–Cataract surgery alone, patients randomized to group
Non-randomized iStent	–	–Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Extended follow-up of subjects previously enrolled in Glaukos Study GC-003

Key inclusion criteria (1 listed)

Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to participate in this extended follow-up study

Key exclusion criteria (2 listed)

Subjects previously enrolled in Glaukos Study GC-003 who are not able or willing to participate in this extended follow-up study
Patients not previously enrolled in Glaukos Study GC-003

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

Rate of Sight-threatening Adverse Events
Time frame: 80 Month average
The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group.

Results and safety

Results posted to the registry on 15 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Randomized iStent	51	51
Randomized Cataract Surgery	35	35
Non-randomized iStent	22	22

Primary outcome: Rate of Sight-threatening Adverse Events

Time frame: 80 Month average. Number. Unit: percentage of subjects

Measure	Randomized iStent n = 51	Randomized Cataract Surgery n = 35	Non-randomized iStent n = 22
Value	27.8	45.7	34.3

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Randomized iStent	0 of 111 (0%)	13 of 111 (11.7%)	Not reported
Randomized Cataract Surgery	0 of 122 (0%)	15 of 122 (12.3%)	Not reported
Non-randomized iStent	0 of 46 (0%)	6 of 46 (13%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Primary Open Angle Glaucoma

RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
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Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
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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.

Jeff Wells, PharmD, MBA study director

Glaukos Corporation

Jay Katz, MD study chair

Wills Eye Institute; Thomas Jefferson University

26 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 26 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 2 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 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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?

Yes. Results are posted in the registry (first posted 15 Apr 2016). 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?

Rate of Sight-threatening Adverse Events (time frame: 80 Month average). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01836042.

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 15 Apr 2016; AzTrials last refreshed its copy on 29 Oct 2026.