Recruiting

OMNI Surgical System

Sponsor:

Mark Gallardo, MD

Code:

NCT04530084

Conditions

Open Angle Glaucoma

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

OMNI Surgical System

Study Details

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

Conditions

Open Angle Glaucoma

Study ID

NCT04530084

Start date

Aug 21, 2020

Status verified date

Aug, 2020

Completion date

Dec, 2021

Anticipated

Primary completion date

Aug 22, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Diagnosed with open angle glaucoma

Interventions

OMNI Surgical System

Scheduled for canaloplasty and trabeculotomy with or without cataract extraction

Primary outcome measure

  • Adverse events (intraoperative and perioperative) [ Time Frame: 3 months ]
  • Best Corrected Visual Acuity (BCVA) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Mark Gallardo, MD

(915) 542-0279gallardomark@hotmail.com

Locations

El Paso Eye Surgeons

Recruiting

El Paso, Texas, United States, 79902

More Information

Sponsor

Mark Gallardo, MD

Last update posted

Aug 28, 2020

Last verified

Aug, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mark Gallardo, MD on 2020-08-28.