Status:
TERMINATED
Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty
Lead Sponsor:
Nova Eye, Inc.
Conditions:
Primary Open Angle Glaucoma
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
A prospective, multicenter, randomized, single-masked clinical trial to evaluate the effectiveness outcomes of canaloplasty performed as a standalone procedure with the iTrack microcatheter to the Omn...
Eligibility Criteria
Inclusion
- Diagnosed with mild to moderate open angle Glaucoma.
- Visual Field test (Humphrey SITA standard 24-2) with mean deviation better than or equal to -12.0 dB
- IOP \< or = to 36 mmHG while on one to four ocular hypotensive medications
- Shaffer grade of \> or = III in all four quadrants
- Able and willing to comply with the Protocol and follow up visits for 12 months
Exclusion
- Laser trabeculoplasty other than selective laser trabeculoplasty (SLT)
- History of iStent or iStent inject within 180 days of the screening visit
- History of ECP or Micropulse laser
- Trabeculectomy or other bleb forming procedure including Xen, Express and glaucoma drainage device/valves
- Prior canaloplasty (ab interno and ab externo)
- Prior goniotomy or trabeculotomy
- History of Hydrus microstent or suprachoroidal stent
- History of cataract surgery within 6 months of screening
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary or pseudoexfoliative glaucoma
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04769453
Start Date
April 29 2021
End Date
January 26 2023
Last Update
March 15 2023
Active Locations (7)
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1
Arizona Advanced Eye Research Institute
Glendale, Arizona, United States, 85306
2
Beverly Hills Institute of Ophthalmology
Beverly Hills, California, United States, 90210
3
Coastal Vision
Orange, California, United States, 92868
4
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104