Glaucoma, Primary Open AngleNCT05999006
Safety and Feasibility of the ELIOS System in POAG Patients
A study testing ELIOS Procedure in people with Glaucoma, Primary Open Angle, run by Elios Vision, Inc. at 6 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Glaucoma, Primary Open Angle
- What is being tested?
- ELIOS Procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Oct 2023to 28 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 corticosteroid responder Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Elios Vision Clinical Site
El Paso, Texas, 79902
Elios Vision Clinical Site
Glendale, Arizona, 85306
Elios Vision Clinical Site
Kenosha, Wisconsin, 53142
Elios Vision Clinical Site
Oklahoma City, Oklahoma, 73112
Elios Vision Clinical Site
Rock Island, Illinois, 61201
Elios Vision Clinical Site
St Louis, Missouri, 63108
About this study
Official title: A Prospective, Multicenter, Clinical Trial Designed to Evaluate the Safety and Feasibility of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma as a Standalone Procedure
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)
- Conditions
- Glaucoma, Primary Open Angle
- Being tested
- ELIOS Procedure
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELIOS ProcedureDevice
Treatment with the ELIOS System
| Study group | Role | What they receive |
|---|---|---|
| ELIOS Procedure | Experimental | ELIOS Procedure Receives: Device: ELIOS Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Months
Mean Change in DIOP from baseline on the same or fewer medications
Mean Change in DIOP from baseline on the same or fewer medications
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start18 Oct 2023
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Primary Open AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elios Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iqbal (Ike) Ahmed, MD, Study director, Prism Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999006
- Sponsor's protocol ID
- EP-02
- Status last verified
- Jun 2026
- First submitted
- 11 Aug 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Clinical Trial Designed to Evaluate the Safety and Feasibility of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma as a Standalone Procedure
- ClinicalTrials.gov ID
- NCT05999006
- Acronym / sponsor ID
- EP-02
- Conditions
- Glaucoma, Primary Open Angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Elios Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ELIOS Procedure | Experimental | Device: ELIOS ProcedureELIOS Procedure |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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 corticosteroid responder Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELIOS ProcedureTreatment with the ELIOS System | Device | ELIOS Procedure |
Primary outcome
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
Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications
Mean Change in DIOP from baseline on the same or fewer medications
Time frame: 12 Months
Mean Change in DIOP from baseline on the same or fewer medications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iqbal (Ike) Ahmed, MD study director
Prism Eye Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELIOS Procedure in people with Glaucoma, Primary Open Angle, run by Elios Vision, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.