A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System
Not Applicable
- Conditions
- Open Angle Glaucoma
- Interventions
- Device: OMNI Surgical System
- Registration Number
- NCT04530084
- Lead Sponsor
- Mark Gallardo, MD
- 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 (intraoperative and perioperative) 2) BCVA 3) Secondary surgical interventions 4) mean IOP and 5) mean number of hypotensive medications
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnosed with open angle glaucoma OMNI Surgical System -
- Primary Outcome Measures
Name Time Method Best Corrected Visual Acuity (BCVA) 3 months Adverse events (intraoperative and perioperative) 3 months
- Secondary Outcome Measures
Name Time Method Mean intraocular pressure (IOP) 3 months Mean number of ocular hypotensive medications 3 months
Trial Locations
- Locations (1)
El Paso Eye Surgeons
🇺🇸El Paso, Texas, United States