Actively Recruiting
A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX)
Led by Sight Sciences, Inc. · Updated on 2025-07-16
25
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 (IOP) 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, with a stable medication regimen for at least 2 months
- Diagnosed with mild to moderate primary open angle glaucoma (POAG)
You will not qualify if you...
- Laser trabeculoplasty within 180 days prior to baseline
- Durysta implant within 12 months prior to baseline
- Any implanted glaucoma device
- Prior canaloplasty, goniotomy, trabeculotomy, or trabeculectomy
- Ciliary ablation including endoscopic cyclophotocoagulation (ECP), cyclophotocoagulation, or high intensity focused ultrasound within 180 days prior to baseline
- Retinal laser procedure within 3 months prior to baseline
- Any form of glaucoma other than POAG
- Use of topical ocular steroids
- Clinically significant ocular or systemic conditions increasing risk of complications or affecting 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 (BCVA) of logMAR 0.4 (20/50) or worse in study eye not due to cataract
- BCVA of logMAR 0.6 (20/80) or worse in non-study eye not due to cataract
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Panama Eye Center
Panama City, Panama
Actively Recruiting
Research Team
J
Jaime Dickerson, PhD
CONTACT
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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