Feasibility Clinical Evaluation of the Calibreye System
Recruiting · NCT05885022 · Interventional (participants receive a specific treatment) · Lead sponsor: Myra Vision Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Calibreye System
What this trial is about
To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
4 locations listed.
- Dr. Agarwal's Eye Hospital Ltd. - Chennai, India
- Centro Oftalmologico de Chihuahua - Chihuahua City, Mexico
- Panama Eye Center - Panama City, Panama
- Oftalmología Láser de Puebla S.C. - Puebla City, Mexico