A Pilot Study of the Helix Surgical System in Subjects With Primary Open-Angle Glaucoma (POAG) and Cataract.
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Panama
Panama Eye Center
RECRUITING
Panama City
Contact Information
Primary
Jaime Dickerson, PhD
jdickerson@sightsciences.com
+1 (817) 845-0859
Time Frame
Start Date: 2025-05-21
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 25
Treatments
Experimental: POAG and Cataracts
Subjects diagnosed with mild to moderate primary open angle glaucoma (POAG) and cataracts in the study eye.
Related Therapeutic Areas
Sponsors
Leads: Sight Sciences, Inc.