VisiPlate Glaucoma Implant: Implant (micro-shunt) for glaucoma patients
Study summary
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
Eligibility
Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Open angle, pseudoexfoliative or pigmentary glaucoma
* IOP at preoperative visit of ≥ 20mmHg and ≤ 40mmHg
* Visual field mean deviation score of -3dB or worse
* Area of healthy, free and mobile conjunctiva in the target quadrant
* Shaffer angle grade ≥ 2 in the target quadrant
Exclusion Criteria:
* Angle closure glaucoma
* Congenital, neovascular or other secondary glaucomas
* Previous intraocular surgery, with the exception of uncomplicated cataract surgery
* Previous glaucoma shunt/valve in the target quadrant
* Clinically significant inflammation or infection in the study eye within 30 days prior to the operative visit
* History of corneal surgery, corneal opacities or corneal disease
* Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition
Primary outcome measure(s)
Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure — 12 Months The eye is filled with a special fluid. The intraocular pressure is the amount of fluid that builds up in the eye. The primary outcome is the number of people whose eye pressure went down by at least 20%.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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