A Randomized Clinical Trial of Ab Interno Canaloplasty and Trabeculotomy with the OMNI® Surgical System Compared to Standard Medical Treatment as a Standalone Procedure in Patients with Primary Open Angle Glaucoma (EVOLVE)
This prospective, multicenter, post-market clinical trial will evaluate the safety and effectiveness of canaloplasty and trabeculotomy using the OSS as a standalone procedure in patients with POAG.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
The OMNI Surgical System is 510(k) cleared and indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma
* Latanoprost ophthalmic solution (0.005%) is a topical prostaglandin F2 analog used in the treatment of Glaucoma. * Adjunctive topical glaucoma medication(s) as selected by the Investigator
North Bay Eye Associates
Petaluma, California, United States
University Eye Specialists
Maryville, Tennessee, United States
Subjects with a ≥ 20% reduction
Proportion of subjects with a ≥ 20% reduction from medicated baseline in mean diurnal IOP (DIOP) at 12 months post-operatively
Time frame: 12 months
Diurnal IOP (DIOP) between 6 and 18 mmHg (inclusive)
Proportion of eyes at 12 months post-randomization, with mean medicated diurnal IOP (DIOP) between 6 and 18 mmHg (inclusive).
Time frame: 12 months
Number of Ocular Hypotensive Medications
Mean number of ocular hypotensive medications used at 12 months
Time frame: 12 months
Tear break-up time (TBUT)
Proportion of eyes with a minimal clinically important difference (MCID) defined as a 1 category improvement, in tear beak-up time (TBUT)
Time frame: 12 months
Corneal or conjunctival staining
Proportion of eyes with improvement in corneal staining or conjunctival staining by at least one category with no worsening in either at 12 months compared to baseline.
Time frame: 12 months
OSDI score
Proportion of subjects with a MCID in ocular surface disease index (OSDI) score at 12 months compared to baseline
Time frame: 12 months
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