Status:
TERMINATED
Standalone OMNI Surgical System for Open-angle Glaucoma
Lead Sponsor:
Iqbal Ahmed
Collaborating Sponsors:
OMNI Medical Services, LLC
Conditions:
Open Angle Glaucoma
Eligibility:
All Genders
30-95 years
Brief Summary
The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential innovative surgical alternatives to help better control intraocular pressure (IOP). The OMNI™ Surgical Sys...
Detailed Description
The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential innovative surgical alternatives to help better control intraocular pressure (IOP).1 The OMNI™ Surgical Sy...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients aged 30-95 with primary or pigmentary / pseudoexfolliative / juvenile / normal pressure open angle glaucoma or combined mechanism glaucoma.
- An IOP of 10-40 mmHg on maximum tolerated medical therapy who are either progressing, above IOP target, or poorly adherent or tolerant to medical therapy.
- Phakic or pseudophakic eyes and previous laser trabeculoplasty will be included.
- Exclusion Criteria:
- Other forms of glaucoma,
- prior incisional glaucoma surgery,
- prior corneal graft (PKP, DALK, DSAEK, DMEK),
- Shafer angle grading \<2 in 2 or more quadrants.
Exclusion
Key Trial Info
Start Date :
March 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04427995
Start Date
March 25 2019
End Date
April 1 2021
Last Update
July 26 2021
Active Locations (1)
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1
Prism Eye Institute
Oakville, Ontario, Canada, L6H 0J8