Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty (MAGIC)

Nova Eye, Inc.

Status: Terminated

Conditions: Primary Open Angle Glaucoma

Treatments: Device: Canaloplasty using the iTrack microcatheter with Healon Pro; Device: Canaloplasty using the iTrack microcatheter with Healon GV Pro; Device: Canaloplasty using the Omni surgical system with Healon Pro; Device: Canaloplasty using the Omni surgical system with Healon GV Pro

Study type: Interventional

Funder types: Industry

Identifiers

NCT04769453

NE 01021

Details and patient eligibility

About

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 Omni surgical system, and to compare the effectiveness of two types of Ophthalmic Viscoelastic Device (OVD).

Enrollment: 20 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with mild to moderate open angle Glaucoma.
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

1. Laser trabeculoplasty other than selective laser trabeculoplasty (SLT)
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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20 participants in 4 patient groups

iTrack canaloplasty microcatheter with Healon GV Pro

Active Comparator group

Description:

Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)

Treatment:

Device: Canaloplasty using the iTrack microcatheter with Healon GV Pro

OMNI surgical system with Healon GV Pro

Active Comparator group

Description:

Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)

Treatment:

Device: Canaloplasty using the Omni surgical system with Healon GV Pro

iTrack canaloplasty microcatheter with Healon Pro

Active Comparator group

Description:

Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)

Treatment:

Device: Canaloplasty using the iTrack microcatheter with Healon Pro

OMNI surgical system with Healon Pro

Active Comparator group

Description:

Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)

Treatment:

Device: Canaloplasty using the Omni surgical system with Healon Pro