Back to resultsCataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma (CATALYST)
Primary Purpose
Primary Open Angle Glaucoma
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device
Cataract surgery
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Canaloplasty
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate, primary open angle glaucoma
- Characteristics consistent with mild to moderate glaucoma
- Use of 1 - 4 ocular hypotensive medications at the Screening exam and meets the IOP (intraocular pressure) criteria
- Visually significant cataract
Exclusion Criteria:
Any of the following prior treatments for glaucoma (study eye):
- Laser Trabeculoplasty
- Endocyclophotocoagulation (ECP) or Micropulse laser
- iStent or iStent Inject
- Hydrus Microstent
- Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma drainage device/valve.
- Prior canaloplasty (ab-interno and ab-externo)
- Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN)
- Concurrent IOP-lowering procedure other than use of the iTrackTM Advance canaloplasty device at the time of surgery (e.g., ECP, CPC, etc.)
- Previous treatment with iTrack (Note: permitted if fellow eye only was treated)
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary glaucoma or pseudo exfoliative glaucoma.
Sites / Locations
- Augencentrum Köln OphthalmologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Cataract surgery combined with ab-interno canaloplasty
Control: Cataract surgery
Arm Description
Ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.)
Cataract surgery alone
Outcomes
Primary Outcome Measures
Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline
IOP will be measured at each study visit using Goldmann applanation tonometry
Secondary Outcome Measures
To evaluate the reduction in number of glaucoma medications at 12 months compared to baseline
Full Information
NCT ID
NCT05564091
First Posted
September 29, 2022
Last Updated
February 26, 2023
Sponsor
Nova Eye, Inc.
Collaborators
Nova Eye Medical GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05564091
Brief Title
Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
Acronym
CATALYST
Official Title
Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Eye, Inc.
Collaborators
Nova Eye Medical GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective, multicenter, randomized, single-masked, post-market clinical trial comparing cataract surgery in conjunction with ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) to cataract surgery only in patients with mild to moderate, primary open angle glaucoma. Subjects will be followed for 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
Canaloplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cataract surgery combined with ab-interno canaloplasty
Arm Type
Active Comparator
Arm Description
Ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.)
Arm Title
Control: Cataract surgery
Arm Type
Other
Arm Description
Cataract surgery alone
Intervention Type
Device
Intervention Name(s)
Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device
Intervention Description
360 degree microcatheterization and viscodilation of Schlemm's canal
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Other Intervention Name(s)
Phacoemulsification
Intervention Description
Cataract surgery alone
Primary Outcome Measure Information:
Title
Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline
Description
IOP will be measured at each study visit using Goldmann applanation tonometry
Time Frame
12 months
Secondary Outcome Measure Information:
Title
To evaluate the reduction in number of glaucoma medications at 12 months compared to baseline
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild to moderate, primary open angle glaucoma
Characteristics consistent with mild to moderate glaucoma
Use of 1 - 4 ocular hypotensive medications at the Screening exam and meets the IOP (intraocular pressure) criteria
Visually significant cataract
Exclusion Criteria:
Any of the following prior treatments for glaucoma (study eye):
Laser Trabeculoplasty
Endocyclophotocoagulation (ECP) or Micropulse laser
iStent or iStent Inject
Hydrus Microstent
Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma drainage device/valve.
Prior canaloplasty (ab-interno and ab-externo)
Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN)
Concurrent IOP-lowering procedure other than use of the iTrackTM Advance canaloplasty device at the time of surgery (e.g., ECP, CPC, etc.)
Previous treatment with iTrack (Note: permitted if fellow eye only was treated)
Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary glaucoma or pseudo exfoliative glaucoma.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mike Pickrel
Phone
800-391-2316
Email
MPickrel@Nova-Eye.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert Koerber, MD
Organizational Affiliation
Augencentrum Köln Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augencentrum Köln Ophthalmology
City
Köln
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert Koerber, MD
Email
nkoerber@gmx.de
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
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