NCT06948773 A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX)
| NCT ID | NCT06948773 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sight Sciences, Inc. |
| Condition | Primary Open Angle Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-05-21 |
| Primary Completion | 2026-09-30 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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