Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty

Primary Open Angle Glaucoma Clinical Trial

— MAGIC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04769453
• Other study ID #: NE 01021
• Status: Terminated
• Phase: N/A
• Start date: April 29, 2021
• Est. completion date: January 26, 2023

Study information

• Verified date: March 2023
• Source: Nova Eye, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: January 26, 2023
• Est. primary completion date: January 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Device:
• Canaloplasty using the iTrack microcatheter with Healon GV Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
• Canaloplasty using the Omni surgical system with Healon GV Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
• Canaloplasty using the iTrack microcatheter with Healon Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
• Canaloplasty using the Omni surgical system with Healon Pro
360 degree microcatheterization and viscodilation of Schlemm's canal

Locations

Country	Name	City	State
United States	Beverly Hills Institute of Ophthalmology	Beverly Hills	California
United States	El Paso Eye Surgeons	El Paso	Texas
United States	Arizona Advanced Eye Research Institute	Glendale	Arizona
United States	Eye Centers of Racine and Kenosha	Kenosha	Wisconsin
United States	Cataract and Laser Institute of Southern Oregon	Medford	Oregon
United States	Dean McGee Eye Institute	Oklahoma City	Oklahoma
United States	Coastal Vision	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Nova Eye, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in mean Intraocular pressure (IOP) and glaucoma medication use at 12 months post-intervention	IOP will be measured at each study visit using Goldmann applanation tonometry	12 months
Secondary	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
Secondary	Visual acuity at 12 months compared to baseline visual acuity	Best corrected visual acuity (BCVA) will be assessed using the standard Snellen eye chart	12 months