Actively Recruiting
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
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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 Schlemm's canal and collector channels, and it also allows an intracanalicular scaffolding procedure to restore the eye's 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo cataract surgery combined with the Helix Surgical System intervention and receive immediate post-operative care.
1 surgical visit
Duration - 3 months
Participants attend follow-up visits to monitor recovery, intraocular pressure, and medication use after surgery.
Approximately 6 post-operative visits
Trial Site Locations
Total: 1 location
1
Panama Eye Center
Panama City, Panama
Actively Recruiting
Research Team
J
Jaime Dickerson, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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