A Post-market Study Of Use Of The OMNI® Surgical System In Open Angle Glaucoma

A Prospective, Multi-center, Randomized, Masked, Controlled, Post-market Study Of Use Of The OMNI® Surgical System In Combination With Cataract Extraction In Open Angle Glaucoma (VERITA)

To prospectively compare the clinical effect of the OMNI surgical system in eyes with Open Angle Glaucoma.

Study Overview

• Status: Terminated
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Device: OMNI® Surgical System; Device: iStent inject

Detailed Description

First, to prospectively compare the clinical effect of the transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG) and second, to prospectively compare the clinical effect of the transluminal viscoelastic delivery using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG)

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Eye Center South
  • New Jersey
    • Vineland, New Jersey, United States, 08361
      • Eye Associates and SurgiCenter of Vineland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects, 22 years or older
• Visually significant cataract
• Mild to moderate open angle glaucoma
• On 1-5 IOP-lowering medications
• Potential of good best corrected visual acuity post cataract extraction, in the investigator's judgment
• Able and willing to comply with the protocol, including all follow-up visits.
• Understand and sign the informed consent.

Exclusion Criteria:

• Any of the following prior treatments for glaucoma:

  • Laser trabeculoplasty ≤3 months prior to baseline
  • Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device
  • Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC
• Acute angle closure, normal tension, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subjects' medical record.
• 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).
• Participation (≤ 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the study investigator
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ab-interno transluminal viscoelastic delivery with trabeculotomy using OMNI surgical System	Device: OMNI® Surgical System; Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
Active Comparator: Ab-interno transluminal viscoelastic delivery using OMNI surgical System	Device: OMNI® Surgical System; Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
Active Comparator: iStent Inject implantation; iStent Inject implantation using the iStent device	Device: iStent inject; Trabecular meshwork implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Unmedicated Diurnal Intraocular Pressure (DIOP)	The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eyes With a ≥ 20% Decrease in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) From Baseline	The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.	1 week
Eyes With Unmedicated Diurnal Intraocular Pressure (DIOP) Between 6 and 18 mmHg Inclusive	The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.	1 week
Change in the Number of Ocular Hypotensive Medications Compared to Screening	The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.	1 week
Change in Unmedicated Diurnal Intraocular Pressure (DIOP) From Baseline	The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.	1 week

Collaborators and Investigators

• Sponsor: Sight Sciences, Inc.
• Investigators: Study Chair: Kavita Dhamdhere, MD, PhD, Sight Sciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2020
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 07024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes