Active — Not RecruitingNot Applicable

A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX)

Panama25 participantsStarted 2025-05-21

Plain-language summary

A study to assess the safety of the Helix Surgical System in cataract surgery and to gain early evidence of its effectiveness in lowering intraocular pressure (IOP) in subjects with mild to moderate primary open-angle glaucoma (POAG) and cataracts.

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \< 220…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is listed as 'active, not recruiting' — does that mean enrollment is closed, and if so, are there similar studies using the Helix Surgical System or other MIGS devices that I might still be able to join?
2The trial is combining treatment for both glaucoma and cataracts at the same time — is that the right approach for my specific situation, or would my doctor recommend treating one condition before the other using standard options?
3The main goal of this trial is to see whether the Helix device can lower eye pressure by at least 20% three months after surgery — how does that target compare to what my doctor would aim for with existing, approved glaucoma treatments?
4Since this trial is listed as Phase NA, what does that mean for how much safety and effectiveness data already exists for the Helix Surgical System, and how should that affect my thinking about it compared to established surgical options?
5The three-month follow-up is the key measurement point in this study — what happens to patients' care and monitoring after that window closes, and how would my long-term glaucoma management be handled?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

≥ 20% change from baseline in mean IOP at the 3-month post-operative endpoint

Timeframe: 3 months

Trial details

NCT IDNCT06948773

SponsorSight Sciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Primary Open Angle Glaucoma trials

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.