An interventional study of Vizio Aqueous Microshunt in Refractory Glaucoma, sponsored by Ocumedex. Recruiting at 1 site in El Salvador. Open to participants aged 22 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Ocumedex · Not applicable, Interventional, and Treatment
Evaluate the Safety and Efficacy of the Vizio Aqueous Microshunt for the Treatment of Refractory Glaucoma
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.
1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.
This study's planned enrollment of 50 is below the median of 61 across 964 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →This is the only study on the registry with Ocumedex as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
glaucoma describes eyes diagnosed with glaucoma specific to one of the following:
Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
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:
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 . Exclusion Criteria
Other clinical conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
single-arm clinical study
Device: Vizio Aqueous Microshunt
Ocular microshunt placement for the treatment of Glaucoma
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 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.
Time frame: 12 months
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 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
Time frame: 12 months
Started Mar 2026 (actual). Primary completion is estimated for Jan 2028, 22 months after the start.
Of 58 industry-sponsored interventional studies with no phase under Glaucoma, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 46. This study's planned 22 months is close to that.
Counting every sponsor, half of 287 studies reached it within 30 months; a quarter within 12 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.