NCT06948773Active, not recruiting
A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX)
A Pilot Study of the Helix Surgical System in Subjects With Primary Open-Angle Glaucoma (POAG) and Cataract.
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 21 Apr 2025
- Start date
- 21 May 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Sight Sciences, Inc.
- Diseases
- Glaucoma
- NCT number
- NCT06948773
What you commit to
- Study type: Interventional
- Planned participants: 25
- From 21 May 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- History of penetrating keratoplasty or another corneal transplant
- Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
Age
- Endothelial cell density \< 2200 cells/mm2 (age 45), \< 2000 cells/mm2 (age 46 to 55), \< 1800 cells/mm2 (age 56 to 65), \< 1600 cells/mm2 (age \> 65).
Other
- Any form of glaucoma other than POAG
- BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to cataract
- BCVA of logMAR 0.6 (20/80) or worse in the non-study eye not due to cataract.
Who the study is looking for
- 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).
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Panama Eye Center Coordinator of this site? Confirm its status | Panama City | Panama | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.