Feasibility Clinical Evaluation of the Calibreye System
Not Applicable
Recruiting
- Conditions
- Glaucoma, Open-Angle
- Interventions
- Device: Calibreye System
- Registration Number
- NCT05885022
- Lead Sponsor
- Myra Vision Inc.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Investigational Device Arm Calibreye System Subjects will receive a Calibreye glaucoma device (permanent implant)
- Primary Outcome Measures
Name Time Method Intraocular Pressure 12 Months Percent change in IOP from baseline to the 12-month visit
Adverse Events 12 Months Number and percentage of subjects having any adverse event
- Secondary Outcome Measures
Name Time Method Glaucoma Medication Usage 12 Months Change in number of medications used compared to baseline
Trial Locations
- Locations (4)
Centro Oftalmologico de Chihuahua
🇲🇽Chihuahua, Mexico
Dr. Agarwal's Eye Hospital Ltd.
🇮🇳Chennai, India
Oftalmología Láser de Puebla S.C.
🇲🇽Puebla, Mexico
Panama Eye Center
🇵🇦Panama City, Panama