Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty
NCT ID: NCT04769453
Last Updated: 2023-03-15
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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TERMINATED
NA
20 participants
INTERVENTIONAL
2021-04-29
2023-01-26
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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iTrack canaloplasty microcatheter with Healon GV Pro
Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)
Canaloplasty using the iTrack microcatheter with Healon GV Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
OMNI surgical system with Healon GV Pro
Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)
Canaloplasty using the Omni surgical system with Healon GV Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
iTrack canaloplasty microcatheter with Healon Pro
Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)
Canaloplasty using the iTrack microcatheter with Healon Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
OMNI surgical system with Healon Pro
Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)
Canaloplasty using the Omni surgical system with Healon Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
Interventions
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Canaloplasty using the iTrack microcatheter with Healon GV Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
Canaloplasty using the Omni surgical system with Healon GV Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
Canaloplasty using the iTrack microcatheter with Healon Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
Canaloplasty using the Omni surgical system with Healon Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
Eligibility Criteria
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Inclusion Criteria
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
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
22 Years
ALL
No
Sponsors
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Nova Eye, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shamil Patel, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Eye Physicians and Surgeons of Arizona
Locations
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Arizona Advanced Eye Research Institute
Glendale, Arizona, United States
Beverly Hills Institute of Ophthalmology
Beverly Hills, California, United States
Coastal Vision
Orange, California, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States
Cataract and Laser Institute of Southern Oregon
Medford, Oregon, United States
El Paso Eye Surgeons
El Paso, Texas, United States
Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, United States
Countries
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Other Identifiers
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NE 01021
Identifier Type: -
Identifier Source: org_study_id
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