Open Angle Glaucoma
Conditions
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
Interventions
DEVICEOMNI Surgical System
Scheduled for canaloplasty and trabeculotomy with or without cataract extraction
Sponsors
Mark Gallardo, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects, 22 years or older. 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
1. Any other intraocular surgery at the time of canaloplasty and trabeculotomy excepting cataract surgery for those subjects with cataract. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (intraoperative and perioperative) | 3 months |
| Best Corrected Visual Acuity (BCVA) | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Mean intraocular pressure (IOP) | 3 months |
| Mean number of ocular hypotensive medications | 3 months |
Countries
United States
Contacts
Primary ContactMark Gallardo, MD
Outcome results
None listed