An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma (ORION 2.0)

Glaucoma, Open-Angle Clinical Trial

Official title:

An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma (ORION 2.0)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04872348
• Other study ID #: 07355
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: November 2, 2023

Study information

• Verified date: January 2024
• Source: Sight Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of the OMNI® Surgical System in subjects who have undergone canaloplasty and trabeculotomy using OMNI® Surgical System without any concomitant surgery in pseudophakic eyes with mild to moderate primary open angle glaucoma (POAG) at least 150 days prior to enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2, 2023
• Est. primary completion date: November 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Treated with OMNI® Surgical System as a standalone procedure in pseudophakic eye with mild to moderate primary open angle glaucoma at least 150 days prior to enrollment.

Exclusion Criteria:

• Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits.

• Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications or contraindicate washout, place the subject at risk of significant vision loss during the study period or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits).

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

Device:
• OMNI® Surgical System
The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.

Locations

Country	Name	City	State
United States	Eye Specialists of Georgia	Atlanta	Georgia
United States	Minnesota Eye Consultants	Bloomington	Minnesota
United States	El Paso Eye Surgeons	El Paso	Texas
United States	Ophthalmology Associates - Fort Worth	Fort Worth	Texas
United States	University Eye Specialists	Maryville	Tennessee
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Utah Eye Centers	Ogden	Utah
United States	Oklahoma Eye Surgeons	Oklahoma City	Oklahoma
United States	Northern New Jersey Eye Institute	Orange	New Jersey
United States	Grene Vision Group	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Sight Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in intraocular pressure (IOP)	Decrease in unmedicated mean diurnal IOP (DIOP)	12 months
Primary	Decrease in number of medications	Mean change in the number of ocular hypotensive medications.	12 months