What is the Helix Surgical System studying for primary open-angle glaucoma and cataracts?

The Helix Surgical System is being studied to evaluate its safety and its ability to lower intraocular pressure in people with mild to moderate primary open-angle glaucoma and cataracts. This research is sponsored by Sight Sciences, Inc. and aims to gather early evidence on how this device may help improve eye fluid drainage during cataract surgery.

Who may be eligible for this primary open-angle glaucoma clinical trial?

Adults aged 45 years or older with mild to moderate primary open-angle glaucoma and a visually significant age-related cataract may be eligible. Participants should have intraocular pressure within specified ranges depending on medication use and be stable on their glaucoma medication. This trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this primary open-angle glaucoma clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should consider their own travel arrangements when joining this trial.

Actively Recruiting

Phase Not Applicable

Age: 45Years +

All Genders

ID06948773

A Pilot Study of the Helix Surgical System in Subjects With Primary Open-Angle Glaucoma POAG and Cataract

Led by Sight Sciences, Inc. · Updated on 2025-07-16

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to assess the safety of the Helix Surgical System when used alongside cataract surgery and to gather early evidence on its effectiveness in lowering intraocular pressure IOP in people with mild to moderate primary open-angle glaucoma POAG and cataracts. The study focuses on individuals diagnosed with these eye conditions to better understand the potential benefits and risks of this device. The Helix Surgical System is a handheld device designed to improve eye fluid drainage by viscodilating up to 360 degrees of Schlemms canal and collector channels, and it also allows an intracanalicular scaffolding procedure to restore the eyes aqueous outflow system. Participants will undergo cataract surgery combined with the use of this system to evaluate its impact on IOP and medication use. Participants will be monitored over time with assessments including measurement of intraocular pressure at three months after surgery to determine if there is at least a 20 change from baseline. Researchers will also track changes in the average number of ocular hypotensive medications used. Safety and effectiveness will be evaluated through regular check-ups and eye exams during the study period, which is expected to last several months after the procedure.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 45Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male or female subjects, 45 years or older
Visually significant age-related cataract
Intraocular pressure at screening not exceeding 33 mmHg and at least 21 mmHg for unmedicated eyes or 16 mmHg if medicated with 1 to 4 ocular hypotensive medications
Stable medication regimen for at least 2 months
Diagnosed with mild to moderate primary open-angle glaucoma

You will not qualify if you...

Prior ocular procedures including laser trabeculoplasty within 180 days, Durysta within 12 months, any implanted glaucoma device, canaloplasty, goniotomy, trabeculotomy, trabeculectomy, or ciliary ablation within 180 days
Retinal laser procedure within 3 months prior to baseline
Any glaucoma type other than primary open-angle glaucoma
Use of topical ocular steroids
Clinically significant concurrent ocular or systemic conditions that increase risk or interfere with study compliance
History of penetrating keratoplasty or other corneal transplant
Endothelial cell density below age-specific thresholds
Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome, or conditions causing elevated episcleral venous pressure
Best corrected visual acuity worse than 20/50 in study eye or worse than 20/80 in non-study eye not due to cataract

Research Team

Jaime Dickerson, PhD

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