Open-angle GlaucomaNCT01455467
Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery
A study testing One iStent and Two iStent in people with Open-angle Glaucoma, run by Glaukos Corporation at 1 site in Armenia.
Trial summary
Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma
- What is being tested?
- One iStent and Two iStent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteArmenia
- Study dates
- Sep 2011to 18 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation
- Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)
Who cannot join
- Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye)
- Prior stent implantations (study eye)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery
Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.
- Conditions
- Open-angle Glaucoma
- Being tested
- One iStent, Two iStent
- Keywords
- Open angle glaucoma, Pigmentary glaucoma, Pseudoexfoliative glaucoma
- 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.
One iStentDevice
Implantation of one iStent in conjunction with cataract surgery
Two iStentDevice
Implantation of two iStent in conjunction with cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| One iStent | Active comparator | Implantation of one iStent in conjunction with cataract surgery Receives: Device: One iStent |
| Two iStent | Active comparator | Implantation of two iStent devices in conjunction with cataract surgery Receives: Device: Two iStent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP
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 posted20 Oct 2011 (estimated)
- Study startSep 2011
- Primary completion18 Oct 2019
- Study completion18 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lilit A Voskanyan, MD, PhD, Principal investigator, S.V. Malayan Ophthalmological Center, Yerevan, Armenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455467
- Sponsor's protocol ID
- GCF-024
- Status last verified
- Aug 2022
- First submitted
- 28 Sep 2011
- 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 Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery
- ClinicalTrials.gov ID
- NCT01455467
- Acronym / sponsor ID
- GCF-024
- Conditions
- Open-angle Glaucoma
- Keywords
- Open angle glaucoma, Pigmentary glaucoma, Pseudoexfoliative glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2011 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 20 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.
Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One iStent | Active comparator | Device: One iStentImplantation of one iStent in conjunction with cataract surgery |
| Two iStent | Active comparator | Device: Two iStentImplantation of two iStent devices in conjunction with cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation
- Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)
Key exclusion criteria (2 listed)
- Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye)
- Prior stent implantations (study eye)
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 |
|---|---|---|
| One iStentImplantation of one iStent in conjunction with cataract surgery | Device | One iStent |
| Two iStentImplantation of two iStent in conjunction with cataract surgery | Device | Two iStent |
Primary outcome
Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP
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.
Related trials for Open-angle Glaucoma
Recruiting
A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma
Glaucoma
Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
Primary Open Angle Glaucoma
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.
Glaucoma, Primary Open Angle
Active, not recruiting
Electrical Stimulation for the Treatment of Optic Neuropathies
Glaucoma, Glaucoma, Open-Angle
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Glaucoma, Glaucoma, Open-Angle
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.
Lilit A Voskanyan, MD, PhD principal investigator
S.V. Malayan Ophthalmological Center, Yerevan, Armenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One iStent and Two iStent in people with Open-angle Glaucoma, 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 ≥ 20% vs. baseline mean diurnal IOP (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.