Status:
UNKNOWN
A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System
Lead Sponsor:
Mark Gallardo, MD
Conditions:
Open Angle Glaucoma
Eligibility:
All Genders
22+ years
Phase:
NA
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 (intr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04530084
Start Date
August 21 2020
End Date
December 1 2021
Last Update
August 28 2020
Active Locations (1)
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1
El Paso Eye Surgeons
El Paso, Texas, United States, 79902