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

Glaucoma, Open-Angle Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04616573
• Other study ID #: 07024
• Status: Terminated
• Phase: N/A
• Start date: November 13, 2020
• Est. completion date: January 20, 2021

Study information

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

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

Device:
• OMNI® Surgical System
Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
• iStent inject
Trabecular meshwork implantation

Locations

Country	Name	City	State
United States	Eye Center South	Dothan	Alabama
United States	Eye Associates and SurgiCenter of Vineland	Vineland	New Jersey

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	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	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
Secondary	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
Secondary	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
Secondary	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