Refractory GlaucomaNCT06591117
The Vizio Clinical Study
A study testing Vizio Aqueous Microshunt in people with Refractory Glaucoma, run by Ocumedex at 1 site in El Salvador.
Trial summary
Evaluate the Safety and Efficacy of the Vizio Aqueous Microshunt for the Treatment of Refractory Glaucoma Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Refractory Glaucoma
- What is being tested?
- Vizio Aqueous Microshunt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEl Salvador
- Study dates
- 21 Mar 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 glaucoma.
Show all 43Show fewer
- 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 findings:
- 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 chamber by Spaeth Grade C, D or E for iris insertion (with indentation). 10. Participant has the understanding, ability, and willingness to fully comply with study procedures and postoperative care instructions. 11. Participant understands, is capable and competent to sign the informed consent. Exclusion Criteria
- 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 infection. For purposes of this study, clinically significant is considered any such condition requiring prescription therapy.
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sergio Alvarado contact
El Salvador1 site, 1 recruiting
- Recruiting
Centro de Diabetes Ocular El Dios de Israel, S.A
Colonia Escalón, San Salvadore
Joaquin Flores, Doctor, +50322406800, info@centrodiabetesocular.com
About this study
Official title: The Vizio Clinical Study: A Prospective, Multicenter, Feasibility Clinical Study to Evaluate the Safety and Efficacy of the Vizio Aqueous Microshunt for the Treatment of Refractory Glaucoma
Evaluate the Safety and Efficacy of the Vizio Aqueous Microshunt for the Treatment of Refractory Glaucoma
Read the detailed description
Glaucoma is a leading cause of irreversible blindness in the world and remains a largely unmet clinical need, especially for trial participants with refractory glaucoma. Available aqueous drainage devices may reduce IOP, but often require continued use of medications. Ocumedex is testing the Vizio Aqueous Microshunt (VAM), a promising medical device engineered to safely and consistently lower IOP to a threshold (approximately 12 mmHg) that may halt further damage to the optic nerve without the use of supplemental medication. The Vizio Aqueous Microshunt is a next generation device initially developed by MicroOptx, Inc. In early 2023, Innomedex, LLC acquired the assets of MicroOptx and formed the company, Ocumedex Inc. Ocumedex is now sponsoring the Vizio Clinical Study based on the product development that was conducted by MicroOptx under an ISO13485 compliant quality system inclusive of all development testing that is required prior to human use.
MicroOptx, developed a first-generation device which was named the Beacon Aqueous Microshunt. The Beacon device had undergone early clinical trials in the United States, Canada and Germany in which 55 trial participants were implanted and clinically followed. The results of this clinical work clearly demonstrated the efficacy endpoint of significantly reducing intraocular pressure and alleviating the need for medications. The safety endpoint of the Beacon device had an adverse event rate that was higher than expected and hence further product development was initiated. The elevated adverse event rate was attributed to healing response of the first-generation material, implantation technique andtrial participant selection. Based on this information, the next generation device, Vizio, was developed with a new implant material which has demonstrated significantly improved healing in GLP animal studies.
Additionally, physician training and proctoring has been refined to ensure proper device implantation as well as refined inclusion/exclusion criteria to ensure proper trial participant selection.
Ocumedex is committed to developing technology that is safe and efficacious for the treatment of trial participants suffering from the devasting disease of glaucoma. With product improvements validated by bench and animal testing in addition to clinical trial rigor implemented, the Vizio product is set to initiate human implants and have a meaningful impact for trial participants.
Additionally, unlike other surgical options available, the Vizio device shunts aqueous humor from the anterior chamber to the surface of the eye. This distinction is important: 1) Vizio drains aqueous humor into an open space with a known pressure (atmospheric), which may improve predictability and consistency of IOP control (vs. draining into a closed space, such as bleb or episcleral venous pressure); and 2) Shunting aqueous humor to the tear film, providing lubrication to the eye and improving ocular surface symptoms which are common in trial participants with glaucoma.
- Conditions
- Refractory Glaucoma
- Being tested
- Vizio Aqueous Microshunt
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vizio Aqueous MicroshuntDevice
Ocular microshunt placement for the treatment of Glaucoma
| Study group | Role | What they receive |
|---|---|---|
| Vizio Treatment | Experimental | single-arm clinical study Receives: Device: Vizio Aqueous Microshunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 12 months
Secondary outcomes (2)
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
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start21 Mar 2026
- Primary completionJan 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Vizio Aqueous Microshunt (VAM) - an implantable device intended to reduce intraocular pressure (IOP) by shunting aqueous humor from the anterior chamber to the surface of the eye.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocumedex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591117
- Sponsor's protocol ID
- C100
- Status last verified
- Jul 2026
- First submitted
- 14 Aug 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vizio Clinical Study: A Prospective, Multicenter, Feasibility Clinical Study to Evaluate the Safety and Efficacy of the Vizio Aqueous Microshunt for the Treatment of Refractory Glaucoma
- ClinicalTrials.gov ID
- NCT06591117
- Acronym / sponsor ID
- C100
- Conditions
- Refractory Glaucoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- OcumedexIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the Safety and Efficacy of the Vizio Aqueous Microshunt for the Treatment of Refractory Glaucoma
Detailed description
Glaucoma is a leading cause of irreversible blindness in the world and remains a largely unmet clinical need, especially for trial participants with refractory glaucoma. Available aqueous drainage devices may reduce IOP, but often require continued use of medications. Ocumedex is testing the Vizio Aqueous Microshunt (VAM), a promising medical device engineered to safely and consistently lower IOP to a threshold (approximately 12 mmHg) that may halt further damage to the optic nerve without the use of supplemental medication. The Vizio Aqueous Microshunt is a next generation device initially developed by MicroOptx, Inc. In early 2023, Innomedex, LLC acquired the assets of MicroOptx and formed the company, Ocumedex Inc. Ocumedex is now sponsoring the Vizio Clinical Study based on the product development that was conducted by MicroOptx under an ISO13485 compliant quality system inclusive of all development testing that is required prior to human use.
MicroOptx, developed a first-generation device which was named the Beacon Aqueous Microshunt. The Beacon device had undergone early clinical trials in the United States, Canada and Germany in which 55 trial participants were implanted and clinically followed. The results of this clinical work clearly demonstrated the efficacy endpoint of significantly reducing intraocular pressure and alleviating the need for medications. The safety endpoint of the Beacon device had an adverse event rate that was higher than expected and hence further product development was initiated. The elevated adverse event rate was attributed to healing response of the first-generation material, implantation technique andtrial participant selection. Based on this information, the next generation device, Vizio, was developed with a new implant material which has demonstrated significantly improved healing in GLP animal studies.
Additionally, physician training and proctoring has been refined to ensure proper device implantation as well as refined inclusion/exclusion criteria to ensure proper trial participant selection.
Ocumedex is committed to developing technology that is safe and efficacious for the treatment of trial participants suffering from the devasting disease of glaucoma. With product improvements validated by bench and animal testing in addition to clinical trial rigor implemented, the Vizio product is set to initiate human implants and have a meaningful impact for trial participants.
Additionally, unlike other surgical options available, the Vizio device shunts aqueous humor from the anterior chamber to the surface of the eye. This distinction is important: 1) Vizio drains aqueous humor into an open space with a known pressure (atmospheric), which may improve predictability and consistency of IOP control (vs. draining into a closed space, such as bleb or episcleral venous pressure); and 2) Shunting aqueous humor to the tear film, providing lubrication to the eye and improving ocular surface symptoms which are common in trial participants with glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Vizio Aqueous Microshunt (VAM) - an implantable device intended to reduce intraocular pressure (IOP) by shunting aqueous humor from the anterior chamber to the surface of the eye.
| Arm | Type | Receives |
|---|---|---|
| Vizio Treatment | Experimental | Device: Vizio Aqueous Microshuntsingle-arm clinical study |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (43 listed)
- Age 22-85 years
- Refractory glaucoma describes eyes diagnosed with glaucoma specific to one of the following:
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vizio Aqueous MicroshuntOcular microshunt placement for the treatment of Glaucoma | Device | Vizio Treatment |
Primary outcome
Efficiency of IOP reduction as measured through Applanation Tonometry
Time frame: 12 months
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.
Safety of the Vizio device and procedure as monitored through adverse event reporting. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 12 months
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.
2 secondary outcomes
Responder Rate
Time frame: 12 months
Overall Safety
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergio Alvarado contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vizio Aqueous Microshunt in people with Refractory Glaucoma, run by Ocumedex at 1 site in El Salvador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 43 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jon StGermain (6129617396, jstgermain@ocumedex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of IOP reduction as measured through Applanation Tonometry (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.