A Fellow Eye Comparative Study of the Aquea Intracanalicular Glaucoma Micro-coil Stent and the Alcon Hydrus Glaucoma Microstent

NCT07836855 | Completed

• 1 other identifier: ACT-04
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract Senile; Glaucoma, Open Angle

Keywords

Open Angle Glaucoma; POAG

Outcome Measures

Primary Outcomes (1)

• 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.

  12 Months

Secondary Outcomes (1)

• Secondary Effectiveness Endpoint

  12 Months

Other Outcomes (3)

• Safety Endpoints

  12 Months

• Safety Endpoints

  12 Months

• Safety Endpoints

  12 Months

Study Arms (2)

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

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.

Device: Hydrus® Microstent

Interventions

Aquea Zealix™ DEVICE

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.

Also known as: Stent, MicroCoil

The Aquea Zealix™

Hydrus® Microstent DEVICE

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

Also known as: Stent

The Hydrus® Microstent

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Aquea Health, Inc.: lead

Study Sites (1)

Centro Oftalmologico Robles

Santa Rosa de Copán, Honduras

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Stents

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-center, bilateral, randomized, controlled feasibility study.

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: September 23, 2026
• Study Start: September 16, 2024
• Primary Completion: June 15, 2026
• Study Completion: June 15, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

HO (1)