Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Gl… (NCT07220876) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
United States165 participantsStarted 2025-11-07
Plain-language summary
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
Who can participate
Age range45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure