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
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
Treatments tested in this trial
- Ab-interno canaloplasty utilizing the iTrack Advance device
- Ab-interno canaloplasty utilizing the OMNI Surgical System
Treatment groups
86 Participants
are divided into 2 treatment groupsLocations
5Germany
Breyer Kaymak Klabe Augenchirurgie Düsseldorf Germany
Spain
Hospital Clinico San Carlos, Servicio de Oftalmologia Madrid Spain
United Kingdom
Princess Alexandra Eye Pavilion, NHS Lothian Edinburgh United Kingdom
St. Paul's Eye Unit, Liverpool University Liverpool United Kingdom
Sponsors and collaborators
Nova Eye, Inc.
Lead sponsor
Nova Eye Medical GmbH
Collaborator
Source ClinicalTrials.gov