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

Not Applicable

Terminated

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

• Registration Number: NCT04616573
• Lead Sponsor: Sight Sciences, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-10-30
• Study First Submitted QC: 2020-10-30
• Study First Posted: 2020-11-05
• Study Start: 2020-11-13
• Primary Completion: 2021-01-20
• Study Completion: 2021-01-20
• Results First Submitted: 2022-05-19
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Results First Posted: 2022-12-01
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iStent Inject implantation	iStent inject	iStent Inject implantation using the iStent device
Ab-interno transluminal viscoelastic delivery with trabeculotomy using OMNI surgical System	OMNI® Surgical System	Ab-interno transluminal viscoelastic delivery with trabeculotomy using OMNI surgical System
Ab-interno transluminal viscoelastic delivery using OMNI surgical System	OMNI® Surgical System	Ab-interno transluminal viscoelastic delivery using OMNI surgical System

Primary Outcome Measures

Name	Time	Method
Change in Unmedicated Diurnal Intraocular Pressure (DIOP)	1 week	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.

Secondary Outcome Measures

Name	Time	Method
Eyes With a ≥ 20% Decrease in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) From Baseline	1 week	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.
Change in the Number of Ocular Hypotensive Medications Compared to Screening	1 week	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.
Change in Unmedicated Diurnal Intraocular Pressure (DIOP) From Baseline	1 week	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.
Eyes With Unmedicated Diurnal Intraocular Pressure (DIOP) Between 6 and 18 mmHg Inclusive	1 week	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.

Trial Locations

Locations (2)

Eye Associates and SurgiCenter of Vineland; 🇺🇸 Vineland, New Jersey, United States

Eye Center South; 🇺🇸 Dothan, Alabama, United States