OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
ConditionPrimary Open Angle Glaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorSight Sciences, Inc.
About this trial
To gain early evidence of safety and assess the effectiveness of the intraocular pressure (IOP)-lowering effectiveness of the OMNI 3.0 Surgical System in primary open-angel glaucoma (POAG).
Eligibility criteria
Qualifiers
Male or female subjects, 45 years or older
Visually significant age-related cataract and requiring phacoemulsification cataract surgery, OR, pseudophakic and a minimum of six months since cataract surgery.
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). Diagnosis must include evidence of glaucomatous optic nerve damage or visual field defect consistent with glaucomatous optic nerve damage
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
- OMNI 3.0 Surgical System
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov