RecruitingNot ApplicableNCT06948773

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.

Sponsor

Sight Sciences, Inc.

Enrollment

25 participants

Start Date

May 21, 2025

Study Type

INTERVENTIONAL

Conditions

Cataract Primary Open Angle Glaucoma

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

Min Age: 45 Years

Inclusion Criteria4

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 Criteria16

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),
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.

Interventions

DEVICEHelix 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.