A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX)
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
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
Treatments tested in this trial
- Helix Surgical System
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov