Open Angle GlaucomaNCT06246136
Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery
A study testing ELIOS and Competitor Device in people with Open Angle Glaucoma, run by Elios Vision, Inc. at 16 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- ELIOS and Competitor Device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 16 sitesin 6 countries
- Study dates
- 5 Dec 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects.
- 40 years old or older.
- Diagnosis of mild to moderate primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma:
- Visually significant cataract eligible for phacoemulsification.
Who cannot join
- All forms of angle closure glaucoma
- Secondary glaucoma, including traumatic, neovascular, uveitic, lens-induced, steroid-induced, angle-recession, glaucoma associated with vascular disorders, and glaucoma associated with increased episcleral venous pressure
- Congenital or developmental glaucoma
- 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
Trial locations and contacts
16 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 6 countries
United Kingdom5 sites, 5 recruiting
- Recruiting
ELIOS Clinical Site
East Grinstead
+44 1342 414000
- Recruiting
ELIOS Clinical Site
Edinburgh
+44 131 537 1340
- Recruiting
ELIOS Clinical Site
Guildford
+44 1483 571122
- Recruiting
ELIOS clinical site
London
00442072533411
- Recruiting
ELIOS Clinical Site
Manchester
44 161 276 5522
France3 sites, 3 recruiting
- Recruiting
Elios Clinical Site
Avranches
0033 233686000
- Recruiting
ELIOS Clinical Site
Bordeaux
0033 556795679
- Recruiting
ELIOS clinical site
Paris
0033 148036565
Germany3 sites, 3 recruiting
- Recruiting
ELIOS Clinical Site
Bochum
+49 234 299 0
- Recruiting
Elios clinical site
Bonn
+49 228 28715505
- Recruiting
ELIOS clinical site
Heidelberg
+49 6221 56 6999
Spain3 sites, 3 recruiting
- Recruiting
ELIOS clinical site
Barcelona
+34 936 11 80 24
- Recruiting
ELIOS Clincal Site
Madrid
+34 915 42 60 10
- Recruiting
ELIOS Clinical site
Madrid
+34 913 30 30 00
Belgium1 site, 1 recruiting
- Recruiting
ELIOS Clinical Site
Leuven
+32 16 33 23 70
Netherlands1 site, 1 recruiting
- Recruiting
ELIOS Clinical Site
Maastricht
31 43 387 6800
About this study
Official title: A Prospective, Multicenter, Randomized Clinical Trial to Evaluate the Safety and Effectiveness of ELIOS vs Competitor in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery
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.
- Conditions
- Open Angle Glaucoma
- Being tested
- ELIOS, Competitor Device
- Keywords
- Excimer Laser, Micro-bypass, Trabeculostomy
- 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.
ELIOSProcedure or surgery
Following cataract surgery, surgeon will proceed to ELIOS treatment.
Competitor DeviceProcedure or surgery
Following cataract surgery, surgeon will proceed to Competitor treatment.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | ELIOS Receives: Procedure: ELIOS |
| Arm 2 | Active comparator | Competitor Device Receives: Procedure: Competitor Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRIMARY EFFECTIVENESS ENDPOINTS : IOP
Mean change in post-washout diurnal IOP from baseline to 12 months.
Measured: 12 months
Secondary outcomes (4)
SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP
Proportion of patients achieving 20% reduction in post-washout diurnal IOP from baseline.
Measured: 24 months
SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications
change in number of hypotensive medications from screening to 12 months
Measured: 12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP
Mean change in treated IOP from screening to 12 months
Measured: 12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Medications
Proportion of patients Medication free at 12 months
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 posted7 Feb 2024
- Study start5 Dec 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elios Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246136
- Sponsor's protocol ID
- ELIOS-RCT STERLING
- Status last verified
- Jun 2026
- First submitted
- 30 Jan 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Clinical Trial to Evaluate the Safety and Effectiveness of ELIOS vs Competitor in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT06246136
- Acronym / sponsor ID
- ELIOS-RCT STERLING
- Conditions
- Open Angle Glaucoma
- Keywords
- Excimer Laser, Micro-bypass, Trabeculostomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Elios Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Feb 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Procedure: ELIOSELIOS |
| Arm 2 | Active comparator | Procedure: Competitor DeviceCompetitor Device |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects.
- 40 years old or older.
- Diagnosis of mild to moderate primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma:
- Visually significant cataract eligible for phacoemulsification.
Key exclusion criteria (4 listed)
- All forms of angle closure glaucoma
- Secondary glaucoma, including traumatic, neovascular, uveitic, lens-induced, steroid-induced, angle-recession, glaucoma associated with vascular disorders, and glaucoma associated with increased episcleral venous pressure
- Congenital or developmental glaucoma
- 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
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 |
|---|---|---|
| ELIOSFollowing cataract surgery, surgeon will proceed to ELIOS treatment. | Procedure or surgery | Arm 1 |
| Competitor DeviceFollowing cataract surgery, surgeon will proceed to Competitor treatment. | Procedure or surgery | Arm 2 |
Primary outcome
PRIMARY EFFECTIVENESS ENDPOINTS : IOP
Time frame: 12 months
Mean change in post-washout diurnal IOP from baseline to 12 months.
4 secondary outcomes
SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP
Time frame: 24 months
SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications
Time frame: 12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP
Time frame: 12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Medications
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELIOS and Competitor Device in people with Open Angle Glaucoma, run by Elios Vision, Inc. at 16 sites in 6 countries.
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 4 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: looking for participants now, as of the sponsor's last update on 17 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 16 sites in United Kingdom, France, Germany, Spain, Belgium and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cameron Hudson (+33388308811, Cameron.Hudson@bausch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRIMARY EFFECTIVENESS ENDPOINTS : IOP (time frame: 12 months). 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 17 Jun 2026.