Cataract SenileNCT07836855
A Fellow Eye Comparative Study of the Aquea Intracanalicular Glaucoma Micro-coil Stent and the Alcon Hydrus Glaucoma Microstent
A study testing Aquea Zealix™ and Hydrus® Microstent in people with Cataract Senile and Glaucoma, Open Angle, run by Aquea Health, Inc. at 1 site in Honduras.
Trial summary
The purpose of this research study is to compare the safety and effectiveness of the Aquea Intracanalicular Glaucoma Stent to the Alcon Hydrus Glaucoma Microstent for the reduction of intraocular pressure (IOP) in patients with cataract and primary open angle glaucoma. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cataract Senile, Glaucoma, Open Angle
- What is being tested?
- Aquea Zealix™ and Hydrus® Microstent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteHonduras
- Study dates
- 16 Sep 2024to 15 Jun 2026
- Phase
- Interventional
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals 45 years of age or older, of either gender or any race, at the time of surgery.
- Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits.
- A diagnosis of cataract eligible for phacoemulsification cataract extraction and IOL implantation.
- A diagnosis of primary open angle glaucoma (POAG) substantiated using funduscopic exam and/or at least one reliable visual field test (i.e., mean deviation < 0 with fixation losses ≤ 30%, false positive errors ≤ 30% and false negative errors ≤ 30%) with the Humphrey automated perimeter using the SITA Standard 24-2 testing algorithm.
- At the Screening Visit, medicated IOP of ≤ 25 mmHg or unmedicated IOP of ≥ 21 mmHg and ≤ 33 mmHg.
- At the Baseline Visit, a mean unmedicated IOP of ≥ 21 mmHg and ≤ 33 mmHg. The mean will be derived from the diurnal IOP readings taken over the course of the Baseline Visit. Additionally, the baseline mean unmedicated diurnal IOP must be ≥ 3 mmHg higher than the medicated IOP measured at the Screening Visit.
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- No changes in preoperative ocular hypotensive medication regimen for at least three months prior to Screening Visit.
- Gonioscopy confirming normal angle anatomy at site of implantation.
- Shaffer grade ≥ III in all four quadrants.
- Intraoperative Inclusion Criteria
- Uncomplicated cataract extraction
- A well-centered posterior chamber IOL implanted in the capsular bag.
- A clear view of an open angle and visualization of the angle with direct gonioscopy post intracameral miotic instillation.
Who cannot join
- Use of more than 3 ocular hypotensive medications. (Combination medications count as 2 or 3 medications depending on number of active ingredients.)
- Use of oral hypotensive medication treatment for glaucoma in the either eye.
- Significant risk by a washout of medication including those subjects with advanced glaucoma evidenced by an afferent pupillary defect, a C:D ratio ≥ 0.9 or encroachment of field loss within the central 5 degrees as indicated by ≥ 2 depressed points of 0.5% probability on the 24-2 SITA Standard Humphrey visual field.
- Previous glaucoma procedure with or without an implantable glaucoma device (with exception of laser treatments to the trabecular meshwork such as a Laser Trabeculoplasty performed more than three months prior to study enrollment).
- Proliferative or severe nonproliferative diabetic retinopathy.
- Previous surgery for retinal detachment.
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- Central corneal thickness > 620 microns.
- Clinically significant corneal dystrophy.
- Previous corneal surgery, except for pterygium excision and corneal relaxing incisions.
- Wet age-related macular degeneration.
- Clinically significant ocular pathology, other than glaucoma.
- Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, elevated episcleral venous pressure, pigmentary or neovascular glaucoma.
- Best corrected visual acuity worse than 20/80 in either eye not attributable to cataract.
- Clinically significant ocular inflammation or infection in either eye within thirty days prior to screening.
- Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's health at risk and/or prevent the subject from completing all study visits.
- Participation in any clinical trial within the 30 calendar days prior to Screening.
- Pregnant or nursing females. -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to compare the safety and effectiveness of the Aquea Intracanalicular Glaucoma Stent to the Alcon Hydrus Glaucoma Microstent for the reduction of intraocular pressure (IOP) in patients with cataract and primary open angle glaucoma.
- Conditions
- Cataract Senile, Glaucoma, Open Angle
- Being tested
- Aquea Zealix™, Hydrus® Microstent
- Keywords
- Open Angle Glaucoma, POAG
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquea Zealix™Device
Also called Stent, MicroCoil
The Zealix stent is a helical shaped stent with variable pitch across the length of the implant specifically designed to keep Schlemm's canal adequately dilated to its natural healthy diameter. The stent has been designed to reduce IOP by restoring the conventional outflow pathway for aqueous humor, specifically Schlemm's canal (SC). Additionally, the Apquea Zealix stent is also designed to provide a by-pass for the aqueous humor fluid to enter Schlemm's canal and flow unobstructed to access the collector channels for drainage.
Hydrus® MicrostentDevice
Also called Stent
The Hydrus® Microstent is an FDA approved device. It is a crescent-shaped implantable microstent pre-loaded onto a hand-held delivery system. It is composed of nitinol, a metal alloy of nickel (Ni) and titanium (Ti). The microstent is approximately 8mm in overall length with major and minor axes of 292μm and 185μm, respectively. The length and curvature of the implant are designed to occupy approximately 90° or 3 clock hours of Schlemm's canal. The implant is designed to have adequate structural thickness to support the tissue of the canal while providing maximum open flow areas through the canal, with the proximal portion of the implant exiting the canal through the trabecular meshwork to allow inflow of aqueous humor from the anterior chamber. A further description of the device and delivery system, and a summary of pre-clinical and clinical testing, can be found in Instructions for Use (IFU) provided by the manufacturer with the device
| Study group | Role | What they receive |
|---|---|---|
| The Aquea Zealix™ | Experimental | The Aquea Zealix™ is a helical shaped micro-coil stent with variable pitch across the length of the implant specifically designed to keep the Schlemm's canal adequately dilated to its natural healthy state Receives: Device: Aquea Zealix™ |
| The Hydrus® Microstent | Active comparator | The Hydrus® Microstent is an FDA approved device. It is a crescent-shaped implantable microstent pre-loaded onto a hand-held delivery system. Receives: Device: Hydrus® Microstent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Proportion of eyes with ≥ 20% decrease in IOP from the hypotensive medication-free baseline examination to the hypotensive medication-free 12-month postoperative examination.
Measured: 12 Months
Secondary outcomes (1)
Secondary Effectiveness Endpoint
Mean change in IOP between the hypotensive medication-free baseline examination and hypotensive medication-free 12-month postoperative examination.
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 posted23 Sep 2026
- Study start16 Sep 2024
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SenileStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, single-center, bilateral, randomized, controlled feasibility study.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aquea Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836855
- Sponsor's protocol ID
- ACT-04
- Status last verified
- Sep 2026
- First submitted
- 10 Jul 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No