Glaucoma, Open-AngleNCT03255785
Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One iStent and One iStent Supra
A study testing Cataract surgery plus one iStent and one iStent Supra implanted in people with Glaucoma, Open-Angle, run by Glaukos Corporation at 1 site in Armenia.
Trial summary
Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular micro-bypass stent and one suprachoroidal stent Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Cataract surgery plus one iStent and one iStent Supra implanted
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteArmenia
- Study dates
- 1 May 2018to 3 Dec 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
- Clinically significant cataract requiring surgery Primary open-angle or pseudoexfoliative glaucoma Visual field defects no worse than -12dB Subject on two ocular hypotensive medications at screening Medicated IOP at screening between 18 and 30 mm Hg Normal iridocorneal anatomy Absence of peripheral anterior synechiae
Who cannot join
- Monocular subjects or those with wore than 20/200 vision in fellow eye Prior stent implantation, incision glaucoma surgery, or laser trabeculoplasty in study eye Traumatic, uveitic, or neovascular glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One Trabecular Micro-bypass Stent and One Suprachoroidal Stent
Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular micro-bypass stent and one suprachoroidal stent
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Cataract surgery plus one iStent and one iStent Supra implanted
- 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.
Cataract surgery plus one iStent and one iStent Supra implantedDevice
Cataract surgery via phacoemulsfication plus one iStent and one iStent supra
| Study group | Role | What they receive |
|---|---|---|
| G1 plus G3 with phaco | Experimental | Cataract surgery via phacoemulsification followed by implantation of one iStent and one iStent Supra Receives: Device: Cataract surgery plus one iStent and one iStent Supra implanted |
What is being measured
The primary outcome is the main question the study is designed to answer.
20% IOP reduction from baseline
IOP measured via Goldmann tonometry in mm Hg and compared to baseline IOP
Measured: Month 12
Secondary outcomes (1)
IOP less than or equal to 18 mm Hg
IOP measured via Goldmann tonometry in mm Hg
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start1 May 2018
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- iStent and iStent Supra
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT03255785
- Sponsor's protocol ID
- GCF-040
- Status last verified
- Sep 2022
- First submitted
- 17 Aug 2017
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One Trabecular Micro-bypass Stent and One Suprachoroidal Stent
- ClinicalTrials.gov ID
- NCT03255785
- Acronym / sponsor ID
- GCF-040
- Conditions
- Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 21 Aug 2017 (actual)
- 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.
Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular micro-bypass stent and one suprachoroidal stent
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- iStent and iStent Supra
| Arm | Type | Receives |
|---|---|---|
| G1 plus G3 with phaco | Experimental | Device: Cataract surgery plus one iStent and one iStent Supra implantedCataract surgery via phacoemulsification followed by implantation of one iStent and one iStent Supra |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically significant cataract requiring surgery Primary open-angle or pseudoexfoliative glaucoma Visual field defects no worse than -12dB Subject on two ocular hypotensive medications at screening Medicated IOP at screening between 18 and 30 mm Hg Normal iridocorneal anatomy Absence of peripheral anterior synechiae
Key exclusion criteria (1 listed)
- Monocular subjects or those with wore than 20/200 vision in fellow eye Prior stent implantation, incision glaucoma surgery, or laser trabeculoplasty in study eye Traumatic, uveitic, or neovascular glaucoma
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 |
|---|---|---|
| Cataract surgery plus one iStent and one iStent Supra implantedCataract surgery via phacoemulsfication plus one iStent and one iStent supra | Device | G1 plus G3 with phaco |
Primary outcome
20% IOP reduction from baseline
Time frame: Month 12
IOP measured via Goldmann tonometry in mm Hg and compared to baseline IOP
1 secondary outcome
IOP less than or equal to 18 mm Hg
Time frame: Month 12
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 9 Sep 2022.
- Individual participant dataSharing planned: No
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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 Cataract surgery plus one iStent and one iStent Supra implanted in people with Glaucoma, Open-Angle, 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 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 9 Sep 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?
20% IOP reduction from baseline (time frame: Month 12). 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 9 Sep 2022.