A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System
Not Applicable
- Conditions
- Open Angle Glaucoma
- 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
- Primary Outcome Measures
Name Time Method Adverse events (intraoperative and perioperative) 3 months Best Corrected Visual Acuity (BCVA) 3 months
- Secondary Outcome Measures
Name Time Method Mean intraocular pressure (IOP) 3 months Mean number of ocular hypotensive medications 3 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie IOP reduction via OMNI Surgical System canaloplasty in open-angle glaucoma?
How does OMNI Surgical System compare to standard trabeculectomy in adverse event rates and IOP control for POAG patients?
Which ocular biomarkers predict successful hypotensive medication reduction post-OMNI canaloplasty?
What are the perioperative complication management strategies for OMNI Surgical System in glaucoma surgery?
Are there combination therapies involving OMNI Surgical System and PG analogs to enhance glaucoma treatment outcomes?
Trial Locations
- Locations (1)
El Paso Eye Surgeons
🇺🇸El Paso, Texas, United States
El Paso Eye Surgeons🇺🇸El Paso, Texas, United States