Trials / Unknown
UnknownNCT04530084
A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Mark Gallardo, MD · Academic / Other
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OMNI Surgical System | Scheduled for canaloplasty and trabeculotomy with or without cataract extraction |
Timeline
- Start date
- 2020-08-21
- Primary completion
- 2021-08-22
- Completion
- 2021-12-01
- First posted
- 2020-08-28
- Last updated
- 2020-08-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04530084. Inclusion in this directory is not an endorsement.