A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX) (HELIX)

A Pilot Study of the Helix Surgical System in Subjects With Primary Open-Angle Glaucoma (POAG) and Cataract.

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Open Angle Glaucoma; Cataract
• Intervention / Treatment: Device: Helix Surgical System

Detailed Description

To assess the safety of the Helix Surgical System with cataract surgery and gain early evidence on intraocular pressure (IOP) -lowering effectiveness in subjects with mild-moderate primary open-angle glaucoma (POAG) and cataract.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jaime Dickerson, PhD; Phone Number: +1 (817) 845-0859; Email: jdickerson@sightsciences.com

Study Locations

• Panama
  • Panama City, Panama
    • Recruiting
    • Panama Eye Center
    • Contact: Idabel Orillac; Email: iorillac@panamaeyecenter.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: POAG and Cataracts; Subjects diagnosed with mild to moderate primary open angle glaucoma (POAG) and cataracts in the study eye.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
≥ 20% change from baseline in mean IOP at the 3-month post-operative endpoint	Proportion of subjects with a ≥ 20% change from baseline in mean IOP at the 3-month post-operative endpoint and on the same or fewer medications as preoperatively.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean IOP	Change in mean IOP at 3 months post-operatively	3 months
Average number of ocular hypotensive medications	Average number of ocular hypotensive medications used at 3 months	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of ocular adverse events (AE)	Rate of intraoperative and postoperative ocular adverse events (AE)	3 months

Collaborators and Investigators

• Sponsor: Sight Sciences, Inc.
• Investigators: Study Director: Jaime Dickerson, PhD, Sight Sciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 21, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Ocular Hypertension; Cataract; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 09637

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No