One surgery, two problems: new device takes on glaucoma and cataracts together

NCT ID NCT06948773

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests a new device called the Helix Surgical System in people who have both primary open-angle glaucoma and cataracts. The device is used during cataract surgery to open up the eye's natural drainage channels, which may help lower eye pressure. The goal is to see if the device is safe and can reduce the need for glaucoma medications. The study involves 25 adults aged 45 and older with mild to moderate glaucoma.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Helix Surgical System (a handheld device that opens drainage channels in the eye)
What this could lead to
If successful, this device could offer a single-surgery option to treat both glaucoma and cataracts, potentially reducing the need for daily eye drops.
What could go wrong
This is a small, early pilot study with only 25 participants, so results may not apply to everyone. The device is new, and long-term safety and effectiveness are not yet known.

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

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

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

45 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female subjects, 45 years or older * Visually significant age-related cataract. * Intraocular pressure (IOP) at the Screening visit not exceeding 33 mmHg and at least 21 mmHg for unmedicated eyes or 16 mmHg if medicated (1 to 4 ocular hypotensive medications - fixed combinations count as the number of components), with a stable medication regimen for ≥2 months. * Diagnosed with mild to moderate primary open angle glaucoma (POAG). Exclusion Criteria: * Any of the following prior ocular procedures: * Laser trabeculoplasty ≤180 days prior to baseline * Durysta ≤12 months prior to baseline * Any implanted glaucoma device * Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy * Ciliary ablation including endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe), high intensity focused ultrasound (HIFU), * 180 days prior to baseline * Retinal laser procedure ≤3 months prior to baseline * Any form of glaucoma other than POAG * Use of topical ocular steroids. * Clinically significant concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period or interfere with compliance to elements of the study protocol * History of penetrating keratoplasty or another corneal transplant * Endothelial cell density \< 2200 cells/mm2 (age 45), \< 2000 cells/mm2 (age 46 to 55), \< 1800 cells/mm2 (age 56 to 65), \< 1600 cells/mm2 (age \> 65). * Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. * BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to cataract * BCVA of logMAR 0.6 (20/80) or worse in the non-study eye not due to cataract.

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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.

Contacts and locations

Locations

  • Panama Eye Center

    Panama City, Panama

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