ClinicalTrials.gg
CompletedNCT04899063ELTGTSUpdated Jun 16, 2026

Excimer Laser Trabeculostomy Glaucoma Treatment Study

An interventional study of ELIOS Procedure in Glaucoma, Primary Open Angle, sponsored by Elios Vision, Inc.. Completed at 20 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

From the registry’s dates

  • Primary completion was Jul 2025, 1 year 3 months ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in Jun 2026.
Phase
Not applicable
Study type
Interventional
Enrollment
318
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) undergoing cataract surgery

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 318 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
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
  • Operable cataract, eligible for phacoemulsification with a BCVA of 20/40 or worse
  • Medicated IOP of \<=24 mmHg
  • Unmedicated diurnal IOP of >=22 mmHg and \<=34 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
318 participants (actual)

Study arms

  • Other
    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 medication-free mean diurnal IOP (DIOP) from baseline of at least 20%

    Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20%

    Time frame: 24 Month

Secondary outcomes

  1. Mean Change in medication-free DIOP from baseline

    Mean change in medication-free DIOP from baseline

    Time frame: 24 Month

07

Study locations

20 sites
  • ELIOS Vision Clinical Site
    Glendale, Arizona 85306, United States
  • ELIOS Vision Clinical Site
    Petaluma, California 94954, United States
  • ELIOS Vision Clinical Site
    Fort Collins, Colorado 80528, United States
  • ELIOS Vision Clinical Site
    Grand Junction, Colorado 81501, United States
  • ELIOS Vision Clinical Site
    DeLand, Florida 32720, United States
  • ELIOS Vision Clinical Site
    Largo, Florida 33770, United States
  • ELIOS Vision Clinical Site
    Melbourne, Florida 32904, United States
  • ELIOS Vision Clinical Site
    Vero Beach, Florida 32960, United States
  • ELIOS Vision Clinical Site
    Rock Island, Illinois 61201, United States
  • ELIOS Vision Clinical Site
    Overland Park, Kansas 66213, United States
  • ELIOS Vision Clinical Site
    Chaska, Minnesota 55318, United States
  • ELIOS Vision Clinical Site
    St Louis, Missouri 63131, United States
  • ELIOS Vision Clinical Site
    Las Vegas, Nevada 89145, United States
  • ELIOS Vision Clinical Site
    South Orange, New Jersey 07079, United States
  • ELIOS Vision Clinical Site
    Oklahoma City, Oklahoma 73112, United States
  • ELIOS Vision Clinical Site
    Duncanville, Texas 75137, United States
  • ELIOS Vision Clinical Site
    El Paso, Texas 79902, United States
  • Elios Vision Clinical Site 2
    San Antonio, Texas 78229, United States
  • ELIOS Vision Clinical Site
    San Antonio, Texas 78229, United States
  • ELIOS Vision Clinical Site
    Kenosha, Wisconsin 53142, United States
08

References and documents

Individual participant data

Plan to share: No — No IPD planned to be shared with other researchers

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
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
NCT04899063
Lead sponsor
Elios Vision, Inc.
Responsible party
Sponsor
First posted
May 24, 2021
Start date
May 10, 2021
Primary completion
Jul 29, 2025
Completion
Jul 29, 2025
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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