Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorAvisi Technologies Inc.

About this trial

A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • VisiPlate Glaucoma Implant

    Device

    Implant (micro-shunt) for glaucoma patients

Treatment groups

165 Participants
are divided into 1 treatment group
Group A: Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure

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%.

Time frame
12 Months

Secondary outcomes

1

Percentage change in mean diurnal IOP

How much the average eye pressure during the day went up or down, shown as a percent.

Time frame
12 months

Other outcomes

Sponsors and contacts

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