An interventional study of ELIOS and Competitor Device in Open Angle Glaucoma, sponsored by Elios Vision, Inc.. Recruiting at 16 sites in 6 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Elios Vision, Inc. · Not applicable, Interventional, and Treatment
The primary study objective is to compare the effectiveness of the combination of phacoemulsification with intraocular lens implant with ELIOS or competitor device in reducing IOP at 12 months postoperatively.
Exclusion Criteria:
ELIOS
Procedure: ELIOS
Competitor Device
Procedure: Competitor Device
Following cataract surgery, surgeon will proceed to ELIOS treatment.
Following cataract surgery, surgeon will proceed to Competitor treatment.
PRIMARY EFFECTIVENESS ENDPOINTS : IOP
Mean change in post-washout diurnal IOP from baseline to 12 months.
Time frame: 12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP
Proportion of patients achieving 20% reduction in post-washout diurnal IOP from baseline.
Time frame: 24 months
SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications
change in number of hypotensive medications from screening to 12 months
Time frame: 12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP
Mean change in treated IOP from screening to 12 months
Time frame: 12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Medications
Proportion of patients Medication free at 12 months
Time frame: 12 months
SAFETY ENDPOINTS : adverse events
Rates of ocular adverse events
Time frame: 24 months
Safety endpoints: Retinal nerve fiber layer thickness
measurement of Retinal nerve fiber layer thickness
Time frame: 12 months (with a planned extension of analysis at 24 months)
Plan to share: Undecided
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Elios Vision, Inc.