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

  • STATUS
    Recruiting
  • days left to enroll
    29
  • participants needed
    30
  • sponsor
    Mark Gallardo, MD
Updated on 25 January 2021
cataract
brimonidine tartrate ophthalmic solution
hypotensive
pigmentary glaucoma
primary open angle glaucoma
trabeculotomy

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

Details
Condition Glaucoma, Pigmentary glaucoma, Open Angle Glaucoma
Treatment OMNI surgical system
Clinical Study IdentifierNCT04530084
SponsorMark Gallardo, MD
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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