Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty

Not Applicable

Terminated

• Conditions: Primary Open Angle Glaucoma
• Interventions: Device: Canaloplasty using the iTrack microcatheter with Healon GV Pro; Device: Canaloplasty using the Omni surgical system with Healon Pro; Device: Canaloplasty using the iTrack microcatheter with Healon Pro; Device: Canaloplasty using the Omni surgical system with Healon GV Pro

• Registration Number: NCT04769453
• Lead Sponsor: Nova Eye, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-21
• Study First Posted: 2021-02-24
• Study Start: 2021-04-29
• Primary Completion: 2023-01-26
• Study Completion: 2023-01-26
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
iTrack canaloplasty microcatheter with Healon GV Pro	Canaloplasty using the iTrack microcatheter with Healon GV Pro	Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)
OMNI surgical system with Healon Pro	Canaloplasty using the Omni surgical system with Healon Pro	Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)
iTrack canaloplasty microcatheter with Healon Pro	Canaloplasty using the iTrack microcatheter with Healon Pro	Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)
OMNI surgical system with Healon GV Pro	Canaloplasty using the Omni surgical system with Healon GV Pro	Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Coastal Vision; 🇺🇸 Orange, California, United States

Beverly Hills Institute of Ophthalmology; 🇺🇸 Beverly Hills, 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

Arizona Advanced Eye Research Institute; 🇺🇸 Glendale, Arizona, United States