Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty

Stopped early · Not applicable

Conditions studied: Primary Open Angle Glaucoma

In brief

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).

Key facts

Study ID

NCT04769453

Run by

Nova Eye, Inc.

People needed

20

Starts

2021-04-29

Expected to finish

2023-01-26

Last updated by the study team

2023-03-15

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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