Study of OMNI Surgical System and iStent for Eyes With OAG (Trident)

NCT04658095 | Terminated Results FDA Device

• 1 other identifier: 07062
• Study Type: interventional
• Target: 10
• Locations: 3 countries
• Sites: 5

Brief 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 canaloplasty alone (using the OMNI Surgical System)to implantation of the iStent Inject in lowering IOP in pseudophakic eyes with OAG.

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (3)

Ab-interno canaloplasty and trabeculotomy using the OMNI Surgical System

ACTIVE COMPARATOR

Sequential canaloplasty (up to 360 degrees) and trabeculotomy (up to 360 degrees)

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)

Device: Canaloplasty

Ab-interno implantation of iStent inject (2 microstents)

ACTIVE COMPARATOR

Implantation of trabecular micro bypass stents as per manufacturer's instructions.

Device: iStent inject

Interventions

Canaloplasty and trabeculotomy with the OMNI system. DEVICE

Ab-interno canaloplasty (360 degrees) and up to 360 degrees trabeculotomy

Ab-interno canaloplasty and trabeculotomy using the OMNI Surgical System

iStent inject DEVICE

Ab-interno implantation of iStent inject (2 microstents)

Ab-interno implantation of iStent inject (2 microstents)

Canaloplasty DEVICE

Ab-interno canaloplasty (360 degrees) using the OMNI

Ab-interno canaloplasty (360 degrees) using the OMNI Surgical System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, 18 years or older
• Pseudophakic
• Diagnosis of open angle glaucoma (OAG)
• On 1-5 ocular hypotensive medications

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Sight Sciences, Inc.: lead

Study Sites (5)

BurgerHospital

Frankfurt, Germany

Location

Institut Catala de Retina (ICR)

Barcelona, 08022, Spain

Location

Universidad Complutense de Madrid

Valencia, 46026, Spain

Location

Paseo Isabel la Católica 1-3. Edificio general Hospital Miguel Servet. Planta calle

Zaragoza, 50009, Spain

Location

Manchester Royal Eye Hospital

Manchester, M13, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: VP, Medical and Clinical Affairs
• Organization: Sight Sciences, Inc.

jdickerson@sightsciences.com

877-266-1144

Study Officials

• Jaime Dickerson, PhD

  Sight Sciences, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: January 11, 2022
• Primary Completion: November 18, 2022
• Study Completion: November 18, 2022
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); ES (3); GB (1)