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

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

Plain Language Summary

Simplified for easier understanding

This study is looking at a new surgical device called the Helix Surgical System for people who have both cataracts and mild-to-moderate open-angle glaucoma (a condition where pressure in the eye damages the optic nerve). The goal is to treat both conditions in a single surgery. **You may be eligible if...** - You are 45 years of age or older - You have a cataract significant enough to affect your vision - You have been diagnosed with mild to moderate primary open-angle glaucoma - Your eye pressure (IOP) falls within the required range at your screening visit - Your glaucoma medication has been stable for at least 2 months **You may NOT be eligible if...** - You have had prior glaucoma surgery or certain laser procedures within the past several months - You have had a prior glaucoma device implanted - You have had certain other eye procedures or conditions affecting the eye's drainage system Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Panama Eye Center

Panama City, Panama

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NCT06948773


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