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

NCT06948773 | Recruiting

• 1 other identifier: 09637
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open Angle Glaucoma; Cataract

Outcome Measures

Primary Outcomes (1)

• ≥ 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 Outcomes (2)

• Change in mean IOP

  3 months

• Average number of ocular hypotensive medications

  3 months

Other Outcomes (1)

• Rate of ocular adverse events (AE)

  3 months

Study Arms (1)

POAG and Cataracts

EXPERIMENTAL

Subjects diagnosed with mild to moderate primary open angle glaucoma (POAG) and cataracts in the study eye.

Device: Helix Surgical System

Interventions

Helix Surgical System DEVICE

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.

POAG and Cataracts

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Sight Sciences, Inc.: lead

Study Sites (1)

Panama Eye Center

Panama City, Panama

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Cataract

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Lens Diseases

Study Officials

• Jaime Dickerson, PhD

  Sight Sciences, Inc.

  STUDY DIRECTOR

Central Study Contacts

Jaime Dickerson, PhD

CONTACT

+1 (817) 845-0859; jdickerson@sightsciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, single-arm, clinical trial

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 29, 2025
• Study Start: May 21, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)