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

Status unconfirmed · Not applicable

Conditions studied: Open Angle Glaucoma

In brief

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

Key facts

Study ID

NCT04530084

Run by

Mark Gallardo, MD

People needed

30

Starts

2020-08-21

Expected to finish

2021-12-01

Last updated by the study team

2020-08-28

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• El Paso Eye Surgeons — El Paso, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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