NCT04530084

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

August 25, 2020

Last Update Submit

August 26, 2020

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (2)

  • Adverse events (intraoperative and perioperative)

    3 months

  • Best Corrected Visual Acuity (BCVA)

    3 months

Secondary Outcomes (2)

  • Mean intraocular pressure (IOP)

    3 months

  • Mean number of ocular hypotensive medications

    3 months

Study Arms (1)

Diagnosed with open angle glaucoma

EXPERIMENTAL
Device: OMNI Surgical System

Interventions

OMNI Surgical SystemDEVICE

Scheduled for canaloplasty and trabeculotomy with or without cataract extraction

Diagnosed with open angle glaucoma

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El Paso Eye Surgeons

El Paso, Texas, 79902, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Central Study Contacts

Mark Gallardo, MD

CONTACT

(915) 542-0279gallardomark@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2020

First Posted

August 28, 2020

Study Start

August 21, 2020

Primary Completion

August 22, 2021

Study Completion

December 1, 2021

Last Updated

August 28, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)