Back to resultsA Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System
Primary Purpose
Open Angle Glaucoma
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OMNI Surgical System
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma
Eligibility Criteria
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.
Sites / Locations
- El Paso Eye SurgeonsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnosed with open angle glaucoma
Arm Description
Outcomes
Primary Outcome Measures
Adverse events (intraoperative and perioperative)
Best Corrected Visual Acuity (BCVA)
Secondary Outcome Measures
Mean intraocular pressure (IOP)
Mean number of ocular hypotensive medications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04530084
Brief Title
A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System
Official Title
A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 21, 2020 (Actual)
Primary Completion Date
August 22, 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark Gallardo, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnosed with open angle glaucoma
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
OMNI Surgical System
Intervention Description
Scheduled for canaloplasty and trabeculotomy with or without cataract extraction
Primary Outcome Measure Information:
Title
Adverse events (intraoperative and perioperative)
Time Frame
3 months
Title
Best Corrected Visual Acuity (BCVA)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mean intraocular pressure (IOP)
Time Frame
3 months
Title
Mean number of ocular hypotensive medications
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Gallardo, MD
Phone
(915) 542-0279
Email
gallardomark@hotmail.com
Facility Information:
Facility Name
El Paso Eye Surgeons
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System
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