A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX)
NCT ID: NCT06948773
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2025-05-21
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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POAG and Cataracts
Subjects diagnosed with mild to moderate primary open angle glaucoma (POAG) and cataracts in the study eye.
Helix Surgical System
A handheld device to viscodilate up to 360 degrees of Schlemm's canal and collector channels that also enables intracanalicular scaffolding procedure to restore the aqueous outflow system of a glaucomatous eye.
Interventions
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Helix Surgical System
A handheld device to viscodilate up to 360 degrees of Schlemm's canal and collector channels that also enables intracanalicular scaffolding procedure to restore the aqueous outflow system of a glaucomatous eye.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 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
* History of penetrating keratoplasty or another corneal transplant
* 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).
* Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
* 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.
45 Years
ALL
No
Sponsors
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Sight Sciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jaime Dickerson, PhD
Role: STUDY_DIRECTOR
Sight Sciences, Inc.
Locations
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Panama Eye Center
Panama City, , Panama
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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09637
Identifier Type: -
Identifier Source: org_study_id
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