Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
NCT ID: NCT05564091
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
78 participants
INTERVENTIONAL
2022-09-08
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Cataract surgery combined with ab-interno canaloplasty
Ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.)
Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device
360 degree microcatheterization and viscodilation of Schlemm's canal
Control: Cataract surgery
Cataract surgery alone
Cataract surgery
Cataract surgery alone
Interventions
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Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device
360 degree microcatheterization and viscodilation of Schlemm's canal
Cataract surgery
Cataract surgery alone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Laser Trabeculoplasty
* Endocyclophotocoagulation (ECP) or Micropulse laser
* iStent or iStent Inject
* Hydrus Microstent
* Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma drainage device/valve.
* Prior canaloplasty (ab-interno and ab-externo)
* Prior goniotomy, or trabeculotomy (ab-interno or ab-externo)
* Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN, MINIject)
* Concurrent IOP-lowering procedure other than use of the iTrackTM Advance canaloplasty device 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 neovascular glaucoma
55 Years
ALL
No
Sponsors
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Nova Eye Medical GmbH
INDUSTRY
Nova Eye, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Norbert Koerber, MD
Role: PRINCIPAL_INVESTIGATOR
Augencentrum Köln Ophthalmology
Locations
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Berkeley Eye Center
Sugar Land, Texas, United States
University of Bonn Eye Clinic
Bonn, , Germany
Augencentrum Köln Ophthalmology
Cologne, , Germany
St. Johannes Hospital
Dortmund, , Germany
Countries
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Central Contacts
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Facility Contacts
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Morgan Micheletti, MD
Role: primary
Karl Mercieca, MD
Role: primary
Markus Kohlhaas, MD
Role: primary
Other Identifiers
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NE 03021
Identifier Type: -
Identifier Source: org_study_id
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