Glaucoma, Open-AngleNCT04658095
Study of OMNI Surgical System and iStent for Eyes With OAG (Trident)
A study testing Canaloplasty and trabeculotomy with the OMNI system., iStent inject and Canaloplasty in people with Glaucoma, Open-Angle, run by Sight Sciences, Inc. at 5 sites in 3 countries.
Trial summary
First, to compare safety and effectiveness outcomes for canaloplasty and trabeculotomy using the OMNI Surgical System to implantation of the iStent inject in lowering intraocular pressure (IOP) in pseudophakic eyes with open angle glaucoma (OAG), and second, to compare safety and effectiveness outcomes for… 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?
- Canaloplasty and trabeculotomy with the OMNI system., iStent inject and Canaloplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 11 Jan 2022to 18 Nov 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 18 years or older
- Pseudophakic
- Diagnosis of open angle glaucoma (OAG)
- On 1-5 ocular hypotensive medications
Who cannot join
- Any of the following prior treatments for glaucoma:
- Suprachoroidal stent (e.g. Cypass, iStent Supra)
- Laser trabeculoplasty ≤ 8 weeks prior to Baseline visit with a MIGS or other glaucoma device including but not limited to iStent, iStent inject, Hydrus, CyPass
- Trabeculectomy or other bleb forming procedure including Xen, PreserFlo, Express, glaucoma draining device/valve
- Prior canaloplasty, goniotomy, or trabeculotomy including procedures with GATT, Kahook Dual Blade, iTrack, Trabectome
- Ciliary ablation procedures including Endocyclophotocoagulation (ECP), Cyclophotocoagulation (G probe), Micropulse laser, or high intensity focused ultrasound (HIFU)
Show all 9Show fewer
- Any other form of glaucoma other than OAG
- Concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet AMD, corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to investigator's office for follow-up visits).
- Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Spain3 sites
Institut Catala de Retina (ICR)
Barcelona, 08022
Universidad Complutense de Madrid
Valencia, 46026
Paseo Isabel la Católica 1-3. Edificio general Hospital Miguel Servet. Planta calle
Zaragoza, 50009
About this study
Official title: A Prospective, Randomized, Multicenter Study To Compare The Safety And Effectiveness Of The OMNI® Surgical System And The iStent Inject In Pseudophakic Eyes With Open Angle Glaucoma. The TRIDENT European Trial
First, to compare safety and effectiveness outcomes for canaloplasty and trabeculotomy using the OMNI Surgical System to implantation of the iStent inject in lowering intraocular pressure (IOP) in pseudophakic eyes with open angle glaucoma (OAG), and second, to compare safety and effectiveness outcomes for canaloplasty alone (using the OMNI Surgical System)to implantation of the iStent Inject in lowering IOP in pseudophakic eyes with OAG.
Read the detailed description
A multicenter, prospective, parallel group study planned to randomize 459 subjects to either 1)canaloplasty + trabeculotomy with the OMNI, 2)canaloplasty alone with the OMNI, or 3)iStent inject in an equal allocation ratio (1:1:1); The study includes baseline and terminal (Month 12) washout. Up to 26 centers in the UK and EU were planned to participate.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Canaloplasty and trabeculotomy with the OMNI system., iStent inject, Canaloplasty
- 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.
Canaloplasty and trabeculotomy with the OMNI system.Device
Ab-interno canaloplasty (360 degrees) and up to 360 degrees trabeculotomy
iStent injectDevice
Ab-interno implantation of iStent inject (2 microstents)
CanaloplastyDevice
Ab-interno canaloplasty (360 degrees) using the OMNI
| Study group | Role | What they receive |
|---|---|---|
| Ab-interno canaloplasty and trabeculotomy using the OMNI Surgical System | Active comparator | Sequential canaloplasty (up to 360 degrees) and trabeculotomy (up to 360 degrees) Receives: Device: Canaloplasty and trabeculotomy with the OMNI system. |
| Ab-interno canaloplasty (360 degrees) using the OMNI Surgical System | Active comparator | Canaloplasty alone (up to 360 degrees) Receives: Device: Canaloplasty |
| Ab-interno implantation of iStent inject (2 microstents) | Active comparator | Implantation of trabecular micro bypass stents as per manufacturer's instructions. Receives: Device: iStent inject |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Unmedicated DIOP From Baseline at the 12-month Postoperative Examination
Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination is the mean of the difference between the baseline DIOP and the Month 12 DIOP for each subject. Baseline and Month 12 DIOP are measured after appropriate washout of any glaucoma medications.
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 posted8 Dec 2020
- Study start11 Jan 2022
- Primary completion18 Nov 2022
- Study completion18 Nov 2022
Why it stopped: Business Decision
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sight Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaime Dickerson, PhD, Study director, Sight Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658095
- Sponsor's protocol ID
- 07062
- Status last verified
- Sep 2025
- First submitted
- 1 Dec 2020
- Last updated
- 27 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Study To Compare The Safety And Effectiveness Of The OMNI® Surgical System And The iStent Inject In Pseudophakic Eyes With Open Angle Glaucoma. The TRIDENT European Trial
- ClinicalTrials.gov ID
- NCT04658095
- Acronym / sponsor ID
- 07062
- Conditions
- Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sight Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Posted 27 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First, to compare safety and effectiveness outcomes for canaloplasty and trabeculotomy using the OMNI Surgical System to implantation of the iStent inject in lowering intraocular pressure (IOP) in pseudophakic eyes with open angle glaucoma (OAG), and second, to compare safety and effectiveness outcomes for canaloplasty alone (using the OMNI Surgical System)to implantation of the iStent Inject in lowering IOP in pseudophakic eyes with OAG.
Detailed description
A multicenter, prospective, parallel group study planned to randomize 459 subjects to either 1)canaloplasty + trabeculotomy with the OMNI, 2)canaloplasty alone with the OMNI, or 3)iStent inject in an equal allocation ratio (1:1:1); The study includes baseline and terminal (Month 12) washout. Up to 26 centers in the UK and EU were planned to participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ab-interno canaloplasty and trabeculotomy using the OMNI Surgical System | Active comparator | Device: Canaloplasty and trabeculotomy with the OMNI system.Sequential canaloplasty (up to 360 degrees) and trabeculotomy (up to 360 degrees) |
| Ab-interno canaloplasty (360 degrees) using the OMNI Surgical System | Active comparator | Device: CanaloplastyCanaloplasty alone (up to 360 degrees) |
| Ab-interno implantation of iStent inject (2 microstents) | Active comparator | Device: iStent injectImplantation of trabecular micro bypass stents as per manufacturer's instructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects, 18 years or older
- Pseudophakic
- Diagnosis of open angle glaucoma (OAG)
- On 1-5 ocular hypotensive medications
Key exclusion criteria (9 listed)
- Any of the following prior treatments for glaucoma:
- Any other form of glaucoma other than OAG
- Concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet AMD, corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to investigator's office for follow-up visits).
- Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
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 |
|---|---|---|
| Canaloplasty and trabeculotomy with the OMNI system.Ab-interno canaloplasty (360 degrees) and up to 360 degrees trabeculotomy | Device | Ab-interno canaloplasty and trabeculotomy using the OMNI Surgical System |
| iStent injectAb-interno implantation of iStent inject (2 microstents) | Device | Ab-interno implantation of iStent inject (2 microstents) |
| CanaloplastyAb-interno canaloplasty (360 degrees) using the OMNI | Device | Ab-interno canaloplasty (360 degrees) using the OMNI Surgical System |
Primary outcome
Mean Change in Unmedicated DIOP From Baseline at the 12-month Postoperative Examination
Time frame: 12 months
Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination is the mean of the difference between the baseline DIOP and the Month 12 DIOP for each subject. Baseline and Month 12 DIOP are measured after appropriate washout of any glaucoma medications.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jaime Dickerson, PhD study director
Sight Sciences, Inc.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canaloplasty and trabeculotomy with the OMNI system., iStent inject and Canaloplasty in people with Glaucoma, Open-Angle, run by Sight Sciences, Inc. at 5 sites in 3 countries.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Germany, United Kingdom. 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 27 Oct 2025). 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?
Mean Change in Unmedicated DIOP From Baseline at the 12-month Postoperative Examination (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 27 Oct 2025.