Clinical trial NCT04769453: Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty
Official title: Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty, Randomized, Controlled Trial: iTrack (Nova Eye Medical) Compared to Omni (Sight Sciences)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Keywords: Canaloplasty
Lead sponsor: Nova Eye, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: A prospective, multicenter, randomized, single-masked clinical trial to evaluate the effectiveness outcomes of canaloplasty performed as a standalone procedure with the iTrack microcatheter to the Omni surgical system, and to compare the effectiveness of two types of Ophthalmic Viscoelastic Device (OVD).


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with mild to moderate open angle Glaucoma.
2. Visual Field test (Humphrey SITA standard 24-2) with mean deviation better than or equal to -12.0 dB
3. IOP \< or = to 36 mmHG while on one to four ocular hypotensive medications
4. Shaffer grade of \> or = III in all four quadrants
5. Able and willing to comply with the Protocol and follow up visits for 12 months

Exclusion Criteria:

1. Laser trabeculoplasty other than selective laser trabeculoplasty (SLT)
2. History of iStent or iStent inject within 180 days of the screening visit
3. History of ECP or Micropulse laser
4. Trabeculectomy or other bleb forming procedure including Xen, Express and glaucoma drainage device/valves
5. Prior canaloplasty (ab interno and ab externo)
6. Prior goniotomy or trabeculotomy
7. History of Hydrus microstent or suprachoroidal stent
8. History of cataract surgery within 6 months of screening
9. Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary or pseudoexfoliative glaucoma

Primary outcomes:
measure: Reduction in mean Intraocular pressure (IOP) and glaucoma medication use at 12 months post-intervention
timeFrame: 12 months
Secondary outcomes:
measure: Complications intra-operatively and post-operatively associated with the iTrack canaloplasty microcatheter compared to complications intra-operatively and post-operatively with the OMNI surgical system.
timeFrame: 12 months
measure: Visual acuity at 12 months compared to baseline visual acuity
timeFrame: 12 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arizona Advanced Eye Research Institute
state: Arizona
city: Beverly Hills
country: United States
facility: Beverly Hills Institute of Ophthalmology
state: California
city: Orange
country: United States
facility: Coastal Vision
state: California
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institute
state: Oklahoma
city: Medford
country: United States
facility: Cataract and Laser Institute of Southern Oregon
state: Oregon
city: El Paso
country: United States
facility: El Paso Eye Surgeons
state: Texas
city: Kenosha
country: United States
facility: Eye Centers of Racine and Kenosha
state: Wisconsin
Study officials:
affiliation: Eye Physicians and Surgeons of Arizona
name: Shamil Patel, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: