ClinicalTrials.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. (part of Bausch Health Companies Inc.) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 11 months later.
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

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 194 is above the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Elios Vision, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

First submitted before Elios Vision, Inc. became part of Bausch Health Companies Inc..

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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, -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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

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.

06

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)

07

Study locations

16 of 16 sites recruiting
  • ELIOS Clinical Site
    Leuven, Belgium
    Recruiting
    • · Contact+32 16 33 23 70
  • Elios Clinical Site
    Avranches, France
    Recruiting
    • · Contact0033 233686000
  • ELIOS Clinical Site
    Bordeaux, France
    Recruiting
    • · Contact0033 556795679
  • ELIOS clinical site
    Paris, France
    Recruiting
    • · Contact0033 148036565
  • ELIOS Clinical Site
    Bochum, Germany
    Recruiting
    • · Contact+49 234 299 0
  • Elios clinical site
    Bonn, Germany
    Recruiting
    • · Contact+49 228 28715505
  • ELIOS clinical site
    Heidelberg, Germany
    Recruiting
    • · Contact+49 6221 56 6999
  • ELIOS Clinical Site
    Maastricht, Netherlands
    Recruiting
    • · Contact31 43 387 6800
  • ELIOS clinical site
    Barcelona, Spain
    Recruiting
    • · Contact+34 936 11 80 24
  • ELIOS Clincal Site
    Madrid, Spain
    Recruiting
    • · Contact+34 915 42 60 10
  • ELIOS Clinical site
    Madrid, Spain
    Recruiting
    • · Contact+34 913 30 30 00
  • ELIOS Clinical Site
    East Grinstead, United Kingdom
    Recruiting
    • · Contact+44 1342 414000
  • ELIOS Clinical Site
    Edinburgh, United Kingdom
    Recruiting
    • · Contact+44 131 537 1340
  • ELIOS Clinical Site
    Guildford, United Kingdom
    Recruiting
    • · Contact+44 1483 571122
  • ELIOS clinical site
    London, United Kingdom
    Recruiting
    • · Contact00442072533411
  • ELIOS Clinical Site
    Manchester, United Kingdom
    Recruiting
    • · Contact44 161 276 5522
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2023 (actual). Primary completion is estimated for Dec 2027, 48 months after the start.

Of 70 industry-sponsored interventional studies with no phase under Glaucoma, Open-Angle, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's planned 48 months is above that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 19 and three quarters within 61.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2024
First posted
Feb 7, 2024
StartActual
Dec 5, 2023
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2028
Last update
Jun 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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