Feasibility Clinical Evaluation of the Calibreye System
Recruiting now · Not applicable
Conditions studied: Glaucoma, Open-Angle
In brief
To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.
Key facts
- Study ID
- NCT05885022
- Run by
- Myra Vision Inc.
- People needed
- 60
- Starts
- 2023-05-31
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2025-12-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Centro Oftalmologico de Chihuahua — Chihuahua City, Mexico (enrolling)
- Oftalmología Láser de Puebla S.C. — Puebla City, Mexico (enrolling)
- Panama Eye Center — Panama City, Panama (enrolling)
- Dr. Agarwal's Eye Hospital Ltd. — Chennai, India
Full record on ClinicalTrials.gov
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