A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System

The overall objective of this study is to determine the safety and usability of OMNI surgical system in performing canaloplasty and trabeculotomy. Outcome measures will include 1) adverse events (intraoperative and perioperative) 2) BCVA 3) Secondary surgical interventions 4) mean IOP and 5) mean number of hypotensive medications

Study Overview

• Status: Unknown
• Conditions: Open Angle Glaucoma
• Intervention / Treatment: Device: OMNI Surgical System

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79902
      • Recruiting
      • El Paso Eye Surgeons

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:

1. Male or female subjects, 22 years or older.
2. Visually significant cataract or pseudophakic with a posterior chamber intraocular lens (PCIOL)
3. Diagnosed with open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma)
4. Scheduled for canaloplasty and trabeculotomy

Exclusion Criteria:

1. Any other intraocular surgery at the time of canaloplasty and trabeculotomy excepting cataract surgery for those subjects with cataract.
2. Prior trabeculectomy, other bleb-forming glaucoma surgery (e.g. tube shunt), or implanted trabecular bypass stents.
3. Any other ocular pathologies that may interfere with the study procedure or be exacerbated by the OMNI procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnosed with open angle glaucoma	Device: OMNI Surgical System; Scheduled for canaloplasty and trabeculotomy with or without cataract extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events (intraoperative and perioperative)	3 months
Best Corrected Visual Acuity (BCVA)	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean intraocular pressure (IOP)	3 months
Mean number of ocular hypotensive medications	3 months

Collaborators and Investigators

• Sponsor: Mark Gallardo, MD

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2020
• Primary Completion (Anticipated): August 22, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 1290569

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