Primary Open-angle GlaucomaNCT01461291
Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
A study testing iStent inject and Cataract surgery in people with Primary Open-angle Glaucoma, run by Glaukos Corporation at 1 site in United States.
Trial summary
Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma. 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?
- iStent inject and Cataract surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 505 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2012to Oct 2018
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate open-angle glaucoma
- Characteristics consistent with mild/moderate glaucoma
- Use of one (1) to three (3) medications at time of screening exam
Who cannot join
- Pigmentary or pseudoexfoliative glaucoma
- Prior incisional glaucoma surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Centers of Racine and Kenosha
Racine, Wisconsin, 53405
About this study
Official title: A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
Read the detailed description
The purpose of this study is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
- Conditions
- Primary Open-angle Glaucoma
- Being tested
- iStent inject, Cataract surgery
- Keywords
- Primary open-angle glaucoma, POAG, Trabecular meshwork, iStent inject
- 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.
iStent injectDevice
Implantation of two GTS400 stents using G2-M-IS iStent inject
Cataract surgeryProcedure or surgery
Cataract surgery alone
| Study group | Role | What they receive |
|---|---|---|
| iStent inject | Experimental | Implantation of two GTS400 stents using G2-M-IS iStent inject Receives: Device: iStent inject |
| Cataract surgery | Active comparator | Cataract surgery alone Receives: Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
≥ 20% Reduction in Intraocular Pressure (IOP)
Measured: Baseline and Month 24
Secondary outcomes (1)
Diurnal IOP Reduction from Baseline
Measured: Baseline and Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study start16 Jan 2012
- Primary completion4 Aug 2017
- Study completionOct 2018
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerry Stephens, O.D., Study chair, Glaukos Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461291
- Sponsor's protocol ID
- GC-008
- Status last verified
- May 2022
- First submitted
- 25 Oct 2011
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
- ClinicalTrials.gov ID
- NCT01461291
- Acronym / sponsor ID
- GC-008
- Conditions
- Primary Open-angle Glaucoma
- Keywords
- Primary open-angle glaucoma, POAG, Trabecular meshwork, iStent inject
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2012 (actual)
- Primary completion
- 4 Aug 2017 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 28 Oct 2011 (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.
Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
Detailed description
The purpose of this study is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iStent inject | Experimental | Device: iStent injectImplantation of two GTS400 stents using G2-M-IS iStent inject |
| Cataract surgery | Active comparator | Procedure: Cataract surgeryCataract surgery alone |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild to moderate open-angle glaucoma
- Characteristics consistent with mild/moderate glaucoma
- Use of one (1) to three (3) medications at time of screening exam
Key exclusion criteria (2 listed)
- Pigmentary or pseudoexfoliative glaucoma
- Prior incisional glaucoma 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 |
|---|---|---|
| iStent injectImplantation of two GTS400 stents using G2-M-IS iStent inject | Device | iStent inject |
| Cataract surgeryCataract surgery alone | Procedure or surgery | Cataract surgery |
Primary outcome
≥ 20% Reduction in Intraocular Pressure (IOP)
Time frame: Baseline and Month 24
1 secondary outcome
Diurnal IOP Reduction from Baseline
Time frame: Baseline and Month 24
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 19 May 2022.
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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.
Kerry Stephens, O.D. study chair
Glaukos Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iStent inject and Cataract surgery in people with Primary Open-angle Glaucoma, run by Glaukos Corporation at 1 site 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 3 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 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
≥ 20% Reduction in Intraocular Pressure (IOP) (time frame: Baseline and Month 24). 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 19 May 2022.