Evaluating the Calibreye System for treating open-angle glaucoma
Feasibility Clinical Evaluation of the Calibreye System
NA · Myra Vision Inc. · NCT05885022
This study is testing a new surgical system to see if it can safely lower eye pressure in people with open-angle glaucoma.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Myra Vision Inc. (industry) |
| Locations | 4 sites (Chennai and 3 other locations) |
| Trial ID | NCT05885022 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and feasibility of the Calibreye System, a surgical intervention designed to reduce intraocular pressure in patients with open-angle glaucoma. It is a prospective, nonrandomized, open-label trial that will evaluate the effectiveness of the procedure in a real-world setting. Participants will be monitored for safety and effectiveness outcomes following the intervention. The study focuses on patients with specific criteria related to their glaucoma condition.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with open-angle, pseudoexfoliative, or pigmentary glaucoma who have specific intraocular pressure and visual field criteria.
Not a fit: Patients with angle closure glaucoma, secondary glaucomas, or those who have had previous intraocular surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a new surgical option for patients with open-angle glaucoma to manage their intraocular pressure effectively.
How similar studies have performed: While this approach is being evaluated for the first time with the Calibreye System, similar interventions have shown promise in managing intraocular pressure in glaucoma patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chennai and 3 other locations
- Dr. Agarwal's Eye Hospital Ltd. — Chennai, India (ACTIVE_NOT_RECRUITING)
- Centro Oftalmologico de Chihuahua — Chihuahua City, Mexico (RECRUITING)
- Oftalmología Láser de Puebla S.C. — Puebla City, Mexico (RECRUITING)
- Panama Eye Center — Panama City, Panama (RECRUITING)
Study contacts
- Study coordinator: Shienal Patel
- Email: info@myravision.com
- Phone: 14085602500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glaucoma, Open-Angle