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

ConditionsPrimary Open Angle GlaucomaCataract
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorSight Sciences, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Laser trabeculoplasty ≤180 days prior to baseline

Durysta ≤12 months prior to baseline

Any implanted glaucoma device

Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: POAG and CataractsExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
3 months

Secondary outcomes

1

Change in mean IOP

Change in mean IOP at 3 months post-operatively

Time frame
3 months
2

Average number of ocular hypotensive medications

Average number of ocular hypotensive medications used at 3 months

Time frame
3 months

Other outcomes

1

Rate of ocular adverse events (AE)

Rate of intraoperative and postoperative ocular adverse events (AE)

Time frame
3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sight Sciences, Inc.

Lead sponsor

Source ClinicalTrials.gov
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