Glaucoma, Primary Open AngleELTGTSNCT04899063
Excimer Laser Trabeculostomy Glaucoma Treatment Study
A study testing ELIOS Procedure in people with Glaucoma, Primary Open Angle, run by Elios Vision, Inc. at 20 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) undergoing cataract surgery 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
- 318 participants
- Where
- 20 sitesUnited States
- Study dates
- 10 May 2021to 29 Jul 2025
- 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
- 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
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
20 sites in 1 country.
20 sites in 1 country
United States20 sites
ELIOS Vision Clinical Site
Chaska, Minnesota, 55318
ELIOS Vision Clinical Site
DeLand, Florida, 32720
ELIOS Vision Clinical Site
Duncanville, Texas, 75137
ELIOS Vision Clinical Site
El Paso, Texas, 79902
ELIOS Vision Clinical Site
Fort Collins, Colorado, 80528
ELIOS Vision Clinical Site
Glendale, Arizona, 85306
ELIOS Vision Clinical Site
Grand Junction, Colorado, 81501
ELIOS Vision Clinical Site
Kenosha, Wisconsin, 53142
ELIOS Vision Clinical Site
Largo, Florida, 33770
ELIOS Vision Clinical Site
Las Vegas, Nevada, 89145
ELIOS Vision Clinical Site
Melbourne, Florida, 32904
ELIOS Vision Clinical Site
Oklahoma City, Oklahoma, 73112
ELIOS Vision Clinical Site
Overland Park, Kansas, 66213
ELIOS Vision Clinical Site
Petaluma, California, 94954
ELIOS Vision Clinical Site
Rock Island, Illinois, 61201
Elios Vision Clinical Site 2
San Antonio, Texas, 78229
ELIOS Vision Clinical Site
San Antonio, Texas, 78229
ELIOS Vision Clinical Site
South Orange, New Jersey, 07079
ELIOS Vision Clinical Site
St Louis, Missouri, 63131
ELIOS Vision Clinical Site
Vero Beach, Florida, 32960
About this study
Official title: A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma Undergoing Cataract Surgery
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
- 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 | Other | 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 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%
Measured: 24 Month
Secondary outcomes (1)
Mean Change in medication-free DIOP from baseline
Mean change in medication-free DIOP from baseline
Measured: 24 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start10 May 2021
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 318 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
- NCT04899063
- Sponsor's protocol ID
- EP-01
- Acronym
- ELTGTS
- Status last verified
- Jun 2026
- First submitted
- 19 May 2021
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD planned to be shared with other researchers
Publications
Gallardo M, Sarkisian SR Jr, Reiss G, Lee A, Singh P, Borisuth N, Yassine M, Swaim K, McCabe C, Duh YJ, Ling HY, Nangia R, Ahmed IIK; ELTGTS Study Investigators. ELIOS Excimer Laser Trabeculostomy with Phacoemulsification in Primary Open-Angle Glaucoma: 24-Month Outcomes of Pivotal Trial. Ophthalmol Glaucoma. 2026 Sep 8:S2589-4196(26)00141-9. doi: 10.1016/j.ogla.2026.08.006. Online ahead of print.
PubMed 42710625
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 Effectiveness of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT04899063
- Acronym / sponsor ID
- ELTGTS / EP-01
- Conditions
- Glaucoma, Primary Open Angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Elios Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 24 May 2021 (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) undergoing cataract surgery
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 | Other | 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 (7 listed)
- 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
Key exclusion criteria (7 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
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 medication-free mean diurnal IOP (DIOP) from baseline of at least 20%
Time frame: 24 Month
Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20%
1 secondary outcome
Mean Change in medication-free DIOP from baseline
Time frame: 24 Month
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.
- Derived from this study: PubMed 42710625Gallardo M, Sarkisian SR Jr, Reiss G, Lee A, Singh P, Borisuth N, Yassine M, Swaim K, McCabe C, Duh YJ, Ling HY, Nangia R, Ahmed IIK; ELTGTS Study Investigators. ELIOS Excimer Laser Trabeculostomy with Phacoemulsification in Primary Open-Angle Glaucoma: 24-Month Outcomes of Pivotal Trial. Ophthalmol Glaucoma. 2026 Sep 8:S2589-4196(26)00141-9. doi: 10.1016/j.ogla.2026.08.006. Online ahead of print.
- Individual participant dataSharing planned: No. No IPD planned to be shared with other researchers
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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
20 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 20 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 7 inclusion and 7 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 20 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 medication-free mean diurnal IOP (DIOP) from baseline of at least 20% (time frame: 24 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04899063, which also lists 1 linked publication.
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.