Last updated: February 14, 2024
Sponsor: Nova Eye, Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Glaucoma
Eye Disorders/infections
Eye Disease
Treatment
Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device
Cataract surgery
Clinical Study ID
NCT05564091
NE 03021
Ages > 55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Mild to moderate, primary open angle glaucoma
- Characteristics consistent with mild to moderate glaucoma
- Use of 1 - 4 ocular hypotensive medications at the Screening exam and meets the IOP (intraocular pressure) criteria
- Visually significant cataract
Exclusion
Exclusion Criteria: Any of the following prior treatments for glaucoma (study eye):
- Laser Trabeculoplasty
- Endocyclophotocoagulation (ECP) or Micropulse laser
- iStent or iStent Inject
- Hydrus Microstent
- Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucomadrainage device/valve.
- Prior canaloplasty (ab-interno and ab-externo)
- Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN)
- Concurrent IOP-lowering procedure other than use of the iTrackTM Advance canaloplastydevice at the time of surgery (e.g., ECP, CPC, etc.)
- Previous treatment with iTrack (Note: permitted if fellow eye only was treated)
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascularglaucoma, pigmentary glaucoma or pseudo exfoliative glaucoma.
Study Design
Total Participants: 78
Treatment Group(s): 2
Primary Treatment: Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device
Phase:
Study Start date:
September 08, 2022
Estimated Completion Date:
October 31, 2025
Connect with a study center
University of Bonn Eye Clinic
Bonn,
GermanyActive - Recruiting
St. Johannes Hospital
Dortmund,
GermanyActive - Recruiting
Augencentrum Köln Ophthalmology
Köln,
GermanyActive - Recruiting
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