A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System
NCT ID: NCT04530084
Last Updated: 2020-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-08-21
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Diagnosed with open angle glaucoma
OMNI Surgical System
Scheduled for canaloplasty and trabeculotomy with or without cataract extraction
Interventions
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OMNI Surgical System
Scheduled for canaloplasty and trabeculotomy with or without cataract extraction
Eligibility Criteria
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Inclusion Criteria
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
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.
22 Years
ALL
No
Sponsors
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Mark Gallardo, MD
OTHER
Responsible Party
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Mark Gallardo, MD
Principal Investigator
Locations
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El Paso Eye Surgeons
El Paso, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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1290569
Identifier Type: -
Identifier Source: org_study_id
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