Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty

Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty, Randomized, Controlled Trial: iTrack (Nova Eye Medical) Compared to Omni (Sight Sciences)

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).

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