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New treatment option for Refractory Glaucoma
Official title The Vizio Clinical Study
ClinicalTrials.gov ID: NCT06591117
What this study is testing
- What it's testing
- Evaluate the Safety and Efficacy of the Vizio Aqueous Microshunt for the Treatment of Refractory Glaucoma
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 85
You may be able to join if
- Age 22-85 years
- Refractory glaucoma describes eyes diagnosed with glaucoma specific to one of the following:
- 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)
You likely can't join if
- 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
- Iridocorneal endothelial syndrome in study eye.
- Uveitic glaucoma in the study eye.
See the full eligibility criteria
Who can join
- Age 22-85 years
- Refractory glaucoma describes eyes diagnosed with glaucoma specific to one of the following:
- 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)
- or have any other condition (e.g., conjunctival scarring, uveitis) in which conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for an eye with uncomplicated primary open angle...
- Primary open-angle or traumatic glaucoma.
- Medicated DIOP ≥25 mmHg and ≤45 mmHg on maximum-tolerated medical therapy that is stable for at least 30 days.
- Best-corrected baseline visual acuity of light perception or better in study eye.
- Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
- Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage;
- Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or
- Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
- Visual field mean deviation (MD) by Humphrey Visual Field: Visual field defects consistent with glaucomatous optic nerve damage and mean deviation worse than -3 dB in the study eye; and at least one of the following two...
- A cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level on the pattern deviation (PD) plot;
- Glaucoma hemi-field test "outside normal limits". 8. At least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 10:00 and 02:00 in the study eye. 9. Adequate space in the anterior...
What rules you out
- 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
- Iridocorneal endothelial syndrome in study eye.
- Uveitic glaucoma in the study eye.
- Epithelial or fibrous downgrowth in the study eye.
- Corneal conditions in study eye inhibiting normal incisional healing (e.g. Fuch's dystrophy) or impair visualization of implant inside the anterior chamber.
- Prior intraocular surgery in study eye within ≤6 months before the preoperative visit (including phacoemulsification).
- Central corneal endothelial cell count of less than 1600 cells/mm2 in study eye.
- Anticipated need for ocular surgery or retinal laser procedure in the study eye within the 12-month follow-up period.
- Need for glaucoma surgery combined with other ocular procedures in study eye at implant (e.g. cataract surgery, penetrating keratoplasty, or retinal surgery).
- Unwilling to discontinue contact lens use in the study eye after surgery.
- Central corneal thickness ≤490μm or ≥620μm in the study eye.
- Clinically significant inflammation or infection in the study eye within 60 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) or any systemic...
- Any condition that prevents the device implantation in the superior region of the study eye.
- Vitreous in the study eye anterior chamber for which a vitrectomy is anticipated.
- Functionally significant cataract in the study eye.
- Other clinical conditions:
- Poorly controlled diabetes (Type I or Type II) as determined by HbA1c \>8 within 3 months of implant.
- Cancer requiring treatment during the duration of the study.
- Any drugs (e.g.: immunosuppressive drugs) or co-morbidity that might inhibit wound healing.
- Participation in any other clinical study during participation in this study.
- Engage in activities that involve submerging their head under water, such as diving or swimming.
- Women who are (i) pregnant, (ii) nursing, (iii) planning a pregnancy and (iv) of childbearing potential not using a reliable method of contraception.
- Life expectancy \<1 year. Note: If both eyes are eligible, the eye with the worse BCVA should be selected
The study team makes the final eligibility decision.
Where it's taking place
- Colonia Escalón, San Salvadore, El Salvador
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colonia Escalón, San Salvadore, El Salvador. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.