ClinicalTrials.gg
CompletedNCT05999006Updated Jun 16, 2026

Safety and Feasibility of the ELIOS System in POAG Patients

An interventional study of ELIOS Procedure in Glaucoma, Primary Open Angle, sponsored by Elios Vision, Inc.. Completed at 6 sites in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Elios Vision, Inc. (part of Bausch Health Companies Inc.) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
45 Years and older
Sex
All
01

Study summary

Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG)

02

Conditions studied

  • Glaucoma, Primary Open Angle

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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 enrollment of 22 is below 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
45 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

  • Diagnosis of mild to moderate POAG
  • Medicated IOP of \<=24 mmHg
  • Shaffer angle grade of III or IV
  • CD ratio \<=0.8
  • At least 45 years old

Exclusion criteria

Exclusion Criteria:

  • Closed-angle and secondary glaucomas
  • Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery
  • Cannot undergo medication washout in the study eye
  • Diagnosis of degenerative visual disorders Non-study eye with BCVA worse than 20/80 Known responder Pregnant or nursing women; or women of not using medically acceptable
Terms in these criteria, in plain language(3)

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    ELIOS Procedure

    ELIOS Procedure

    Device: ELIOS Procedure

Interventions

  • DeviceELIOS Procedure

    Treatment with the ELIOS System

06

What researchers measure

Primary outcomes

  1. Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications

    Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications

    Time frame: 12 Months

  2. Mean Change in DIOP from baseline on the same or fewer medications

    Mean Change in DIOP from baseline on the same or fewer medications

    Time frame: 12 Months

07

Study locations

6 sites
  • Elios Vision Clinical Site
    Glendale, Arizona 85306, United States
  • Elios Vision Clinical Site
    Rock Island, Illinois 61201, United States
  • Elios Vision Clinical Site
    St Louis, Missouri 63108, United States
  • Elios Vision Clinical Site
    Oklahoma City, Oklahoma 73112, United States
  • Elios Vision Clinical Site
    El Paso, Texas 79902, United States
  • Elios Vision Clinical Site
    Kenosha, Wisconsin 53142, United States
08

References and documents

Individual participant data

Plan to share: No

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

Ran from Oct 2023 to primary completion in Apr 2026, 30 months.

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 30 months is close to 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
Aug 11, 2023
First posted
Aug 21, 2023
StartActual
Oct 18, 2023
Primary completionActual
Apr 28, 2026
CompletionActual
Apr 28, 2026
Last update
Jun 16, 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 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05999006
Lead sponsor
Elios Vision, Inc.
Responsible party
Sponsor
First posted
Aug 21, 2023
Start date
Oct 18, 2023
Primary completion
Apr 28, 2026
Completion
Apr 28, 2026
Last update
Jun 16, 2026

Study contacts

Iqbal (Ike) Ahmed, MD
study director · Prism Eye Institute

Oversight

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

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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