Primary Open Angle Glaucoma (POAG)NCT01252849
Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects
A study testing iStent in people with Primary Open Angle Glaucoma (POAG), run by Glaukos Corporation at 1 site in Armenia.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma (POAG)
- What is being tested?
- iStent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteArmenia
- Study dates
- Dec 2010to 8 Oct 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with primary open-angle glaucoma (POAG)
- Subject on two topical hypotensive medications
Who cannot join
- Traumatic, uveitic, neovascular, or angle closure glaucoma
- Fellow eye already enrolled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents
The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.
- Conditions
- Primary Open Angle Glaucoma (POAG)
- Being tested
- iStent
- Keywords
- Open angle, Glaucoma, surgery, Glaucoma, Open-Angle, Ocular Hypertension, Eye Diseases
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Ocular Hypertension, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStentDevice
Implantation of One iStent through a small temporal clear corneal incision.
iStentDevice
Implantation of Two iStents through a small temporal clear corneal incision
iStentDevice
Implantation of Three iStents through a small temperal clear corneal incision
| Study group | Role | What they receive |
|---|---|---|
| First Arm: One iStent, medication | Experimental | Device: One iStent, medication Receives: Device: iStent |
| Second Arm: Two iStents, medication | Experimental | Device: Two iStent devices, medication Receives: Device: iStent |
| Third Arm: Three iStents, medication | Experimental | Device: Three iStent devices, medication Receives: Device: iStent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline
Measured: 12 Months
Secondary outcomes (1)
Mean diurnal IOP <18 mmHg at month 12
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startDec 2010
- Primary completion8 Oct 2019
- Study completion8 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle Glaucoma (POAG)Studies of the same condition, open and under way.
- More trials run by Glaukos CorporationThe sponsor's other registered studies.
- 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
- Model description
- iStent 1, 2, or 3 stents
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252849
- Sponsor's protocol ID
- GCF-016
- Status last verified
- Aug 2022
- First submitted
- 1 Dec 2010
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents
- ClinicalTrials.gov ID
- NCT01252849
- Acronym / sponsor ID
- GCF-016
- Conditions
- Primary Open Angle Glaucoma (POAG)
- Keywords
- Open angle, Glaucoma, surgery, Glaucoma, Open-Angle, Ocular Hypertension, Eye Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2010 (actual)
- Primary completion
- 8 Oct 2019 (actual)
- Study completion
- 8 Oct 2019 (actual)
- First posted
- 3 Dec 2010 (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 evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- iStent 1, 2, or 3 stents
| Arm | Type | Receives |
|---|---|---|
| First Arm: One iStent, medication | Experimental | Device: iStentDevice: One iStent, medication |
| Second Arm: Two iStents, medication | Experimental | Device: iStentDevice: Two iStent devices, medication |
| Third Arm: Three iStents, medication | Experimental | Device: iStentDevice: Three iStent devices, medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with primary open-angle glaucoma (POAG)
- Subject on two topical hypotensive medications
Key exclusion criteria (2 listed)
- Traumatic, uveitic, neovascular, or angle closure glaucoma
- Fellow eye already enrolled
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 |
|---|---|---|
| iStentImplantation of One iStent through a small temporal clear corneal incision. | Device | First Arm: One iStent, medication |
| iStentImplantation of Two iStents through a small temporal clear corneal incision | Device | Second Arm: Two iStents, medication |
| iStentImplantation of Three iStents through a small temperal clear corneal incision | Device | Third Arm: Three iStents, medication |
Primary outcome
Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline
Time frame: 12 Months
1 secondary outcome
Mean diurnal IOP <18 mmHg at month 12
Time frame: 12 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 31 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Primary Open Angle Glaucoma (POAG), run by Glaukos Corporation at 1 site in Armenia.
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 2 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 31 Aug 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 Armenia. 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?
Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline (time frame: 12 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 31 Aug 2022.