The Vizio Clinical Study
ConditionRefractory Glaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-85
SponsorOcumedex
About this trial
Evaluate the Safety and Efficacy of the Vizio Aqueous Microshunt for the Treatment of Refractory Glaucoma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 22-85 years
uncontrolled by maximally tolerated medical therapy
failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt)
failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy)
Disqualifiers
Active neovascular conditions such as active iris or corneal neovascularization, or active proliferative retinopathy in study eye.
Pigmentary glaucoma in study eye.
Angle-closure glaucoma in study eye.
Pseudoexfoliation syndrome in study eye
Trial design
Design model
Single group
Treatments tested in this trial
Vizio Aqueous Microshunt
DeviceOcular microshunt placement for the treatment of Glaucoma
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Vizio TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficiency of IOP reduction as measured through Applanation Tonometry
The primary endpoint is a binary measure of at least 20% reduction from baseline in diurnal IOP at twelve months from baseline. IOP will be measured on day 1, week 1, week 2, month 1, month 2, month 3, month 6, month9, and month 12. Baseline and month 12 IOP measurements will be diurnal. Medication use will be monitored during the follow ups and assessed at month 12 to measure whether participant is on the same number or fewer topical IOP-lowering medications, based on intent-to-treat population.
Time frame
12 months2
Safety of the Vizio device and procedure as monitored through adverse event reporting. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Rate of occurrence of serious procedure-related and/or device-related adverse events (AEs) observed throughout the study will be reported on the AE CRF. Adverse Events, whether related or unrelated to the investigational medical device, include 1) unintended disease or injury, or 2) any unfavorable or untoward clinical signs (including an abnormal laboratory finding). Adverse events (AEs) will be graded by the Investigator based on severity according to the following: • Mild - An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with daily activities. • Moderate - An event that causes some interference with daily activities and may require minimal medical intervention. • Severe - An event that results in significant interference with daily activities, may be incapacitating, requires medical intervention or hospitalization, or is potentially life-threatening • Life-Threatening: The participant is at immediate risk of death.
Time frame
12 monthsSecondary outcomes
1
Responder Rate
Responder rate for complete success at 12M: Defined as at least 20% mean diurnal IOP reduction from baseline after device implant with no IOP lowering medications
Time frame
12 months2
Overall Safety
Rate of all ocular and non-ocular adverse events (intraoperative complications and postoperative events), including rate of pre-specified ocular adverse events (per ANSI Z80.27) and abnormal findings by pachymetry, slit lamp biomicroscopy, gonioscopy, fundoscopy, specular microscopy and patient-reported symptoms
Time frame
12 months Source ClinicalTrials.gov