Phase
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
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)
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 Advancecanaloplasty 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 neovascularglaucoma
Study Design
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
Berkeley Eye Center
Sugar Land, Texas 77478
United StatesActive - Recruiting
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