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

Not Applicable

Terminated

• Conditions: Glaucoma, Open-Angle
• Interventions: Device: OMNI® Surgical System; Device: iStent inject

• Registration Number: NCT04658095
• Lead Sponsor: Sight Sciences, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-08
• Study Start: 2021-12-14
• Status Verified: 2022-08
• Primary Completion: 2022-08-09
• Study Completion: 2022-08-09
• Last Update Submitted: 2022-08-26
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

1. 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)

2. Any other form of glaucoma other than OAG

3. 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).

4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ab-interno canaloplasty and trabeculotomy (both up to 360 degrees) using the OMNI Surgical System	OMNI® Surgical System	-
Ab-interno implantation of iStent inject (2 microstents)	iStent inject	-
Ab-interno canaloplasty (360 degrees) using the OMNI Surgical System	OMNI® Surgical System	-

Primary Outcome Measures

Name	Time	Method
Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination	12 months

Trial Locations

Locations (5)

Universidad Complutense de Madrid; 🇪🇸 Valencia, Spain

Paseo Isabel la Católica 1-3. Edificio general Hospital Miguel Servet. Planta calle; 🇪🇸 Zaragoza, Spain

BurgerHospital; 🇩🇪 Frankfurt, Germany

Institut Catala de Retina (ICR); 🇪🇸 Barcelona, Spain

Manchester Royal Eye Hospital; 🇬🇧 Manchester, United Kingdom