Multicenter Glaucoma Study Investigating Standalone Canaloplasty

ConditionPrimary Open Angle Glaucoma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age22+

SponsorNova Eye, Inc.

About this trial

A multicenter, randomized, clinical trial to evaluate the efficacy of canaloplasty performed as a standalone procedure using the iTrack™ Advance canaloplasty device (Nova Eye, Inc.) as compared to the OMNI® Surgical System (Sight Sciences) in patients with mild to moderate primary open-angle glaucoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female subjects, 22 years or older at the time of surgery

Diagnosed with mild to moderate primary open angle glaucoma

Candidate for canaloplasty surgery: i.e., catheterization of Schlemm's canal and subsequent viscodilation of Schlemm's canal, without trabeculotomy

Intolerance to medical therapy OR need/willingness to reduce medications

Disqualifiers

Laser trabeculoplasty

iStent or iStent Inject within 180 days of the Screening Visit

Endocyclophotocoagulation (ECP) or Micropulse laser

Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma draining device/valve

Trial design

Design model

Parallel

Treatments tested in this trial

Ab-interno canaloplasty utilizing the iTrack Advance device
Device
360 degree microcatheterization and viscodilation of Schlemm's canal
Ab-interno canaloplasty utilizing the OMNI Surgical System
Device
360 degree microcatheterization and viscodilation of Schlemm's canal

Treatment groups

86 Participants

are divided into 2 treatment groups

Group A: iTrack AdvanceActive comparator 1 intervention

Group B: OMNI Surgical SystemActive comparator 1 intervention

Trial outcomes

Primary outcomes

The mean change in unmedicated Intraocular pressure (IOP) at Month-12 compared to baseline

IOP will be measured at each visit with Goldmann applanation tonometry

Time frame

12 months

Percentage of eyes achieving a 20% or greater reduction in unmedicated Intraocular pressure (IOP) at Month-12 compared to baseline and without any other intervention (medication or secondary surgery)

IOP will be measured at each visit with Goldmann applanation tonometry

Time frame

12 months