Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma

Part of paid clinical trials in Sugar Land, Texas.

Sponsor
Nova Eye, Inc.
Study ID
NCT05564091
Status
Recruiting
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Conditions

  • Primary Open Angle Glaucoma

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device — DEVICE
    360 degree microcatheterization and viscodilation of Schlemm's canal
  • Cataract surgery — PROCEDURE
    Cataract surgery alone

Study Details

A prospective, multicenter, randomized, single-masked, post-market clinical trial comparing cataract surgery in conjunction with ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) to cataract surgery only in patients with mild to moderate, primary open angle glaucoma. Subjects will be followed for 24 months.

Key Dates

Start date
Sep 8, 2022
Status verified
Apr 2025
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cataract surgery combined with ab-interno canaloplasty
    Ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.)
  • Other: Control: Cataract surgery
    Cataract surgery alone

Primary Outcome Measure

Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Berkeley Eye CenterSugar LandTexas77478
Morgan Micheletti, MD

Find similar trials in Sugar Land, TX

By research site
Berkeley Eye Center· Sugar Land, TX

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