CClinicalTrials.gg
RecruitingNCT06246136Updated Jun 17, 2026

Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery

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

Phase
Not applicable
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Open Angle Glaucoma

Browse trials for

Keywords

  • Excimer Laser
  • Micro-bypass
  • Trabeculostomy
03

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female subjects.
  2. 40 years old or older.
  3. Diagnosis of mild to moderate primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma:
  4. Visually significant cataract eligible for phacoemulsification.

Exclusion criteria

Exclusion Criteria:

  1. All forms of angle closure glaucoma
  2. Secondary glaucoma, including traumatic, neovascular, uveitic, lens-induced, steroid-induced, angle-recession, glaucoma associated with vascular disorders, and glaucoma associated with increased episcleral venous pressure
  3. Congenital or developmental glaucoma
  4. Prior incisional glaucoma surgery, intraocular surgery or ocular laser treatment of any type with the exception of selective laser trabeculoplasty (SLT) occurring a minimum of 6 months prior to the Screening visit
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
194 participants (estimated)

Study arms

  • Active comparator
    Arm 1

    ELIOS

    Procedure: ELIOS

  • Active comparator
    Arm 2

    Competitor Device

    Procedure: Competitor Device

Interventions

  • ProcedureELIOS

    Following cataract surgery, surgeon will proceed to ELIOS treatment.

  • ProcedureCompetitor Device

    Following cataract surgery, surgeon will proceed to Competitor treatment.

05

What researchers measure

Primary outcomes

  1. PRIMARY EFFECTIVENESS ENDPOINTS : IOP

    Mean change in post-washout diurnal IOP from baseline to 12 months.

    Time frame: 12 months

Secondary outcomes

  1. SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP

    Proportion of patients achieving 20% reduction in post-washout diurnal IOP from baseline.

    Time frame: 24 months

  2. SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications

    change in number of hypotensive medications from screening to 12 months

    Time frame: 12 months

  3. SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP

    Mean change in treated IOP from screening to 12 months

    Time frame: 12 months

  4. SECONDARY EFFECTIVENESS ENDPOINTS : Medications

    Proportion of patients Medication free at 12 months

    Time frame: 12 months

Other outcomes

  1. SAFETY ENDPOINTS : adverse events

    Rates of ocular adverse events

    Time frame: 24 months

  2. 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)

06

Study locations

16 of 16 sites recruiting
  • ELIOS Clinical Site
    Leuven, Belgium
    • · Contact · +32 16 33 23 70
    Recruiting
  • Elios Clinical Site
    Avranches, France
    • · Contact · 0033 233686000
    Recruiting
  • ELIOS Clinical Site
    Bordeaux, France
    • · Contact · 0033 556795679
    Recruiting
  • ELIOS clinical site
    Paris, France
    • · Contact · 0033 148036565
    Recruiting
  • ELIOS Clinical Site
    Bochum, Germany
    • · Contact · +49 234 299 0
    Recruiting
  • Elios clinical site
    Bonn, Germany
    • · Contact · +49 228 28715505
    Recruiting
  • ELIOS clinical site
    Heidelberg, Germany
    • · Contact · +49 6221 56 6999
    Recruiting
  • ELIOS Clinical Site
    Maastricht, Netherlands
    • · Contact · 31 43 387 6800
    Recruiting
  • ELIOS clinical site
    Barcelona, Spain
    • · Contact · +34 936 11 80 24
    Recruiting
  • ELIOS Clincal Site
    Madrid, Spain
    • · Contact · +34 915 42 60 10
    Recruiting
  • ELIOS Clinical site
    Madrid, Spain
    • · Contact · +34 913 30 30 00
    Recruiting
  • ELIOS Clinical Site
    East Grinstead, United Kingdom
    • · Contact · +44 1342 414000
    Recruiting
  • ELIOS Clinical Site
    Edinburgh, United Kingdom
    • · Contact · +44 131 537 1340
    Recruiting
  • ELIOS Clinical Site
    Guildford, United Kingdom
    • · Contact · +44 1483 571122
    Recruiting
  • ELIOS clinical site
    London, United Kingdom
    • · Contact · 00442072533411
    Recruiting
  • ELIOS Clinical Site
    Manchester, United Kingdom
    • · Contact · 44 161 276 5522
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06246136
Lead sponsor
Elios Vision, Inc.
Responsible party
Sponsor
First posted
Feb 7, 2024
Start date
Dec 5, 2023
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jun 17, 2026

Study contacts

Cameron Hudson
Contact
Cameron.Hudson@bausch.com
+33388308811

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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