Back to resultsFeasibility Clinical Evaluation of the Calibreye System
Primary Purpose
Glaucoma, Open-Angle
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Calibreye System
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
Eligibility Criteria
Inclusion Criteria: Open angle, pseudoexfoliative or pigmentary glaucoma IOP at preoperative visit of ≥ 18mmHg and ≤ 45mmHg Visual field mean deviation score of -3dB or worse Area of healthy, free and mobile conjunctiva in the target quadrant Shaffer angle grade ≥ 3 in the target quadrant Exclusion Criteria: Angle closure glaucoma Congenital, neovascular or other secondary glaucomas Previous intraocular surgery (with the exception of laser trabeculoplasty or uncomplicated phacoemulsification with IOL occurring > 3 months prior to the preoperative visit) Previous glaucoma shunt/valve in the target quadrant Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit History of corneal surgery, corneal opacities or corneal disease Active diabetic retinopathy
Sites / Locations
- Dr. Agarwal's Eye Hospital Ltd.Recruiting
- Oftalmología Láser de Puebla S.C.Recruiting
- Panama Eye CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigational Device Arm
Arm Description
Subjects will receive a Calibreye glaucoma device (permanent implant)
Outcomes
Primary Outcome Measures
Intraocular Pressure
Percent change in IOP from baseline to the 12-month visit
Adverse Events
Number and percentage of subjects having any adverse event
Secondary Outcome Measures
Glaucoma Medication Usage
Change in number of medications used compared to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05885022
Brief Title
Feasibility Clinical Evaluation of the Calibreye System
Official Title
Feasibility Clinical Evaluation of the Calibreye System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Myra Vision Inc.
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
To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.
Detailed Description
This is a prospective, nonrandomized, open-label feasibility clinical trial, to evaluate the surgical procedure, safety and effectiveness of the Calibreye System in reducing intraocular pressure in subjects with open angle glaucoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigational Device Arm
Arm Type
Experimental
Arm Description
Subjects will receive a Calibreye glaucoma device (permanent implant)
Intervention Type
Device
Intervention Name(s)
Calibreye System
Other Intervention Name(s)
Glaucoma device, Glaucoma implant, Aqueous Shunt
Intervention Description
Implantation of a glaucoma device to reduce intraocular pressure
Primary Outcome Measure Information:
Title
Intraocular Pressure
Description
Percent change in IOP from baseline to the 12-month visit
Time Frame
12 Months
Title
Adverse Events
Description
Number and percentage of subjects having any adverse event
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Glaucoma Medication Usage
Description
Change in number of medications used compared to baseline
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Open angle, pseudoexfoliative or pigmentary glaucoma
IOP at preoperative visit of ≥ 18mmHg and ≤ 45mmHg
Visual field mean deviation score of -3dB or worse
Area of healthy, free and mobile conjunctiva in the target quadrant
Shaffer angle grade ≥ 3 in the target quadrant
Exclusion Criteria:
Angle closure glaucoma
Congenital, neovascular or other secondary glaucomas
Previous intraocular surgery (with the exception of laser trabeculoplasty or uncomplicated phacoemulsification with IOL occurring > 3 months prior to the preoperative visit)
Previous glaucoma shunt/valve in the target quadrant
Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit
History of corneal surgery, corneal opacities or corneal disease
Active diabetic retinopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Chang
Phone
14085602500
Email
info@myravision.com
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Niksch
Phone
19495336101
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Barton, MD
Organizational Affiliation
Moorfields Eye Hospital NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Dr. Agarwal's Eye Hospital Ltd.
City
Chennai
ZIP/Postal Code
600018
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priyanka Shankar
Phone
(91) 97698 37574
Email
priyanka.s@dragarwal.com
First Name & Middle Initial & Last Name & Degree
Ashvin Agarwal, MD
Facility Name
Oftalmología Láser de Puebla S.C.
City
Puebla
ZIP/Postal Code
72540
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimee Hernandez
Phone
(22) 2257-0970
Email
aimeehdz20@gmail.com
First Name & Middle Initial & Last Name & Degree
Gabriel Salomón Lazcano Gómez, MD
Facility Name
Panama Eye Center
City
Panama City
Country
Panama
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Idabel Orillac
Phone
+507 269 7475
Email
idabelo28@gmail.com
First Name & Middle Initial & Last Name & Degree
Ernesto Calvo, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility Clinical Evaluation of the Calibreye System
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