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

Glaucoma, Open-Angle Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04658095
• Other study ID #: 07062
• Status: Terminated
• Phase: N/A
• Start date: December 14, 2021
• Est. completion date: August 9, 2022

Study information

• Verified date: August 2022
• Source: Sight Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 9, 2022
• Est. primary completion date: August 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

Device:
• OMNI® Surgical System
Ab-interno canaloplasty (360 degrees) and up to 360 degrees trabeculotomy using the OMNI Surgical System
• iStent inject
Ab-interno implantation of iStent inject (2 microstents)
• OMNI® Surgical System
Ab-interno canaloplasty (360 degrees) using the OMNI Surgical System

Locations

Country	Name	City	State
Germany	BurgerHospital	Frankfurt
Spain	Institut Catala de Retina (ICR)	Barcelona
Spain	Universidad Complutense de Madrid	Valencia
Spain	Paseo Isabel la Católica 1-3. Edificio general Hospital Miguel Servet. Planta calle	Zaragoza
United Kingdom	Manchester Royal Eye Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Sight Sciences, Inc.

Countries where clinical trial is conducted

Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination		12 months