Can a tiny eye implant replace glaucoma drops?
NCT ID NCT07754201
First seen Aug 10, 2026 · Last updated Aug 19, 2026 · Updated 3 times
Summary
This trial tests a new device called VividFlo, a small implant placed under the eye's surface to help drain fluid and lower pressure in people with glaucoma. The study involves 10 adults with glaucoma in one eye, who will receive the implant during surgery. Researchers will track eye pressure, the need for pressure-lowering medications, and any safety issues over 12 months. The goal is to see if this implant can safely and effectively control eye pressure and potentially reduce the need for daily eye drops.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VividFlo System (a subconjunctival glaucoma implant placed in the eye using a partial-thickness scleral flap technique)
- What this could lead to
- If successful, this could offer a new surgical option for glaucoma patients to lower eye pressure and reduce reliance on daily eye drops.
- What could go wrong
- This is a very small early study (10 people) focused on safety and feasibility. The implant may not lower pressure enough, or could cause complications like erosion or vision changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age, Capacity \& Consent: 1. Be 18 years of age or older. 2. Be able to understand all study instructions, and willing to comply with all study procedures and the visit schedule. 3. Provide written, informed consent to participate. 2. Glaucoma in the study eye, meeting all of the following requirements: 1. Diagnosed by the investigator, based upon untreated intraocular pressure, disc appearance and visual field abnormalities. 2. The glaucoma type is one of: i. Primary open angle glaucoma (POAG). ii. Chronic angle closure glaucoma (CACG) where the eye is pseudophakic. iii. Mixed mechanism POAG/CACG where a laser iridotomy has previously been performed. iv. Pigmentary open angle glaucoma. v. Exfoliation open angle glaucoma. vi. Neovascular glaucoma that is treated and regressed/quiescent. c. Glaucoma drainage surgery is indicated due to failure of previous treatment (the glaucoma is 'refractory'), with failure of maximum tolerated medical therapy and one of the following circumstances: i. No previous glaucoma surgery. ii. Prior trabecular bypass (using iStents or Hydrus) or cilioablation. iii. Failure of one prior glaucoma drainage operation (that is one of trabeculectomy, deep sclerectomy or Xen). d. The mean diurnal IOP at Baseline is greater than or equal to 20 mmHg and less than or equal to 40 mmHg. e. The conjunctiva in the target quadrant is suitable for glaucoma surgery. Key Exclusion Criteria: * Advanced glaucomatous optic neuropathy that threatens fixation, in the opinion of the investigator. * The glaucoma type is any of the following: 1. Acute Angle Closure Glaucoma (AACG). 2. Chronic Angle Closure Glaucoma (CACG) where the eye is phakic. 3. Congenital glaucoma. Juvenile Open-Angle Glaucoma or Congenital Glaucoma. 4. Secondary glaucoma of any type not specified in the inclusion criteria, including inflammatory glaucoma, active neovascular glaucoma, traumatic glaucoma, Iridocorneal Endothelial (ICE) Syndrome, and silicone oil induced glaucoma. * Previous glaucoma surgery with: 1. A tube-and-plate glaucoma drainage implant (GDI, e.g. Molteno, Baerveldt, Paul). 2. A suprachoroidal implant. 3. Multiple previous operations for glaucoma. 4. Glaucoma surgery within 3 months of screening. * Cataract surgery or any other ocular surgery is indicated at the time of study intervention or is anticipated to be required during the study duration. * Conjunctival scarring or pterygium in the target quadrant. * Severe dry eye disease. * Significant corneal disease. * Accurate measurement of baseline central corneal endothelial density is not possible. * Any treatment or condition that, in the opinion of the investigator, may impact corneal endothelial cell density beyond expected age \& disease-related decline. * Significant retinal or posterior segment pathology, including but not limited to: 1. Active and clinically significant diabetic retinopathy. 2. Active choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, proliferative retinopathy. 3. Intraocular silicone oil. 4. Presence of a scleral buckle. * Vitreous present in the anterior chamber. * Active uveitis or clinically significant infection or inflammation. * Unfit for surgery under local anaesthetic. * Any uncontrolled systemic disease. * The participant is pregnant, breastfeeding, or cannot guarantee they will not conceive or donate sperm or eggs during the study. * Significant risk of bleeding. * Any other clinical or social reason that, in the opinion of the investigator, means standard surgical treatment for glaucoma would be considered safer than participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Melbourne Eye Specialists
Fitzroy, Victoria, 3065, Australia
Contact Email: •••••@•••••
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Other studies related to the condition(s) this trial covers.
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- Can better Follow-Up schedules save sight in glaucoma?
- Portable devices could take the guesswork out of eye pressure checks
- Eye drops may shield the cornea after cataract surgery
- Can a puff of air replace the eye pressure probe?