Primary Open Angle Glaucoma
Conditions
Keywords
Canaloplasty
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 Omni surgical system, and to compare the effectiveness of two types of Ophthalmic Viscoelastic Device (OVD).
Interventions
DEVICECanaloplasty using the iTrack microcatheter with Healon GV Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
DEVICECanaloplasty using the Omni surgical system with Healon GV Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
DEVICECanaloplasty using the iTrack microcatheter with Healon Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
DEVICECanaloplasty using the Omni surgical system with Healon Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
Sponsors
Nova Eye, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in mean Intraocular pressure (IOP) and glaucoma medication use at 12 months post-intervention | 12 months | IOP will be measured at each study visit using Goldmann applanation tonometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications intra-operatively and post-operatively associated with the iTrack canaloplasty microcatheter compared to complications intra-operatively and post-operatively with the OMNI surgical system. | 12 months | — |
| Visual acuity at 12 months compared to baseline visual acuity | 12 months | Best corrected visual acuity (BCVA) will be assessed using the standard Snellen eye chart |
Countries
United States
Outcome results
None listed