GlaucomaELIOSNCT06760169
Efficacy and Safety of the ELIOS Laser in Combined Cataract and Glaucoma Surgery
A study testing Surgery with ELIOS laser in people with Glaucoma, run by Hôpital Privé de la Baie at 1 site in France.
Trial summary
Glaucoma is an irreversible optic neuropathy. It is the second most common cause of blindness worldwide. Glaucoma can be treated with topical medications (eye drops), laser or surgery. Traditional surgery is invasive and has a high complication rate (hypotonia, endophthalmitis, cataracts, etc.). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Surgery with ELIOS laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2025to 28 Feb 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age who agree to take part in the study and have signed an informed consent form
- Visually significant cataract with indication for surgery
- Primary open-angle glaucoma, or secondary open-angle glaucoma (pseudoexfoliative glaucoma or pigmentary glaucoma) with indication for cataract surgery.
- Open iridocorneal angle (Shaffer classification grade 2-4)
- Early to moderate glaucoma (advanced glaucoma, with MD from VFs worse than -12dB, will be excluded)
Who cannot join
- Presence of severe systemic pathologies 2024-A01891-46_Protocol_V6_21112024_Elios Page 20 / 58
- Pregnant or breastfeeding women
- <18 years of age
- Presence of other ophthalmological pathologies (except cataracts), and exclusion of severe dry eye.
- History of intraocular surgery, trauma, or conjunctival scarring in the quadrant intended for surgery
- Visual acuity worse than "counting fingers".
Show all 14Show fewer
- Closure of the iridocorneal angle (and angle-closure glaucoma), angle-closure glaucoma secondary to iridocorneal synechiae, neovascular glaucoma or neovascularization of the iris.
- Normal-pressure glaucoma
- Pachymetry < 490 um or > 620 μm
- Glaucomatous visual field with mean deviation worse than ≤-12 dB
- IOP > 35 mmHg
- Autoimmune disorder, especially collagenosis
- Patient under protective supervision
- Patient not covered by a social security scheme
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Privé de la Baie
Avranches, 50300
Ana Miguel, MD, +332 33 50 90 90
About this study
Glaucoma is an irreversible optic neuropathy. It is the second most common cause of blindness worldwide. Glaucoma can be treated with topical medications (eye drops), laser or surgery. Traditional surgery is invasive and has a high complication rate (hypotonia, endophthalmitis, cataracts, etc.). As a result, several types of micro-invasive surgery (MIGS) have been developed to reduce the risks of surgery while maintaining their effectiveness in lowering intraocular pressure (IOP). The ELIOS laser system is the only ophthalmological excimer laser designed for the surgical treatment of glaucoma. The aim of the procedure is to ablate the trabecular meshwork and inner wall of Schlemm´s canal ab interno, with the creation of 10 microchannels of 210 um in the trabeculum using the ELIOS laser with a wavelength of 308 nm, in order to improve trabecular outflow to achieve a reduction in IOP. The ELIOS laser is an example of Microinvasive Glaucoma surgery (MIGS) with published results demonstrating efficacy and safety. The ELIOS laser is already in use in France (AMM / CE mark achieved). Its use as part of a prospective interventional study will enable us to collect data in order to treat patients more effectively and improve the quality of care provided to glaucoma patients.
- Conditions
- Glaucoma
- Being tested
- Surgery with ELIOS laser
- Keywords
- glaucoma, ELIOS laser, micro-invasive surgery, goniotomy
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with ELIOS laserDevice
This surgery involves visualizing the iridocorneal angle before or after cataract surgery, inserting the ELIOS laser probe into the anterior chamber to come into slight contact with the trabecular meshwork, then pressing the foot pedal, the surgeon activates the laser, which creates a microchannel by photoablating the trabecular meshwork and inner wall of Schlemm´s canal (trabeculostomy) ± 210 um in diameter. This gesture is repeated until 10 microchannels are created. The creation of these microchannels enhances the natural outflow of aqueous humor by bypassing the site of major resistance in the system. The usual duration of the ELIOS procedure is typically few minutes). The rest of the surgery does not deviate from standard phacoemulsification.
| Study group | Role | What they receive |
|---|---|---|
| Elios | Experimental | Not described Receives: Device: Surgery with ELIOS laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP)
This IOP measurement will be carried out using the Goldmann gold standard tonometer, in 2 measurements taken between 8am and 12am, and measured in mmHg
Measured: day 0, 7 and 30, and month 3, 6 and 12 months after surgery
Secondary outcomes (1)
Quality of life
A quality of life questionnaire : 25 questions with Likert scales
Measured: before and after surgery (1, 3, 6 and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start5 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Privé de la Baie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760169
- Sponsor's protocol ID
- 2024-32-PDB
- Acronym
- ELIOS
- Status last verified
- Sep 2026
- First submitted
- 30 Dec 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the ELIOS Laser in Combined Cataract and Glaucoma Surgery
- ClinicalTrials.gov ID
- NCT06760169
- Acronym / sponsor ID
- ELIOS / 2024-32-PDB
- Conditions
- Glaucoma
- Keywords
- glaucoma, ELIOS laser, micro-invasive surgery, goniotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hôpital Privé de la BaieUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 6 Jan 2025 (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.
Glaucoma is an irreversible optic neuropathy. It is the second most common cause of blindness worldwide. Glaucoma can be treated with topical medications (eye drops), laser or surgery. Traditional surgery is invasive and has a high complication rate (hypotonia, endophthalmitis, cataracts, etc.). As a result, several types of micro-invasive surgery (MIGS) have been developed to reduce the risks of surgery while maintaining their effectiveness in lowering intraocular pressure (IOP). The ELIOS laser system is the only ophthalmological excimer laser designed for the surgical treatment of glaucoma. The aim of the procedure is to ablate the trabecular meshwork and inner wall of Schlemm´s canal ab interno, with the creation of 10 microchannels of 210 um in the trabeculum using the ELIOS laser with a wavelength of 308 nm, in order to improve trabecular outflow to achieve a reduction in IOP. The ELIOS laser is an example of Microinvasive Glaucoma surgery (MIGS) with published results demonstrating efficacy and safety. The ELIOS laser is already in use in France (AMM / CE mark achieved). Its use as part of a prospective interventional study will enable us to collect data in order to treat patients more effectively and improve the quality of care provided to glaucoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elios | Experimental | Device: Surgery with ELIOS laser |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥ 18 years of age who agree to take part in the study and have signed an informed consent form
- Visually significant cataract with indication for surgery
- Primary open-angle glaucoma, or secondary open-angle glaucoma (pseudoexfoliative glaucoma or pigmentary glaucoma) with indication for cataract surgery.
- Open iridocorneal angle (Shaffer classification grade 2-4)
- Early to moderate glaucoma (advanced glaucoma, with MD from VFs worse than -12dB, will be excluded)
Key exclusion criteria (14 listed)
- Presence of severe systemic pathologies 2024-A01891-46_Protocol_V6_21112024_Elios Page 20 / 58
- Pregnant or breastfeeding women
- <18 years of age
- Presence of other ophthalmological pathologies (except cataracts), and exclusion of severe dry eye.
- History of intraocular surgery, trauma, or conjunctival scarring in the quadrant intended for surgery
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 |
|---|---|---|
| Surgery with ELIOS laserThis surgery involves visualizing the iridocorneal angle before or after cataract surgery, inserting the ELIOS laser probe into the anterior chamber to come into slight contact with the trabecular meshwork, then pressing the foot pedal, the surgeon activates the laser, which creates a microchannel by photoablating the trabecular meshwork and inner wall of Schlemm´s canal (trabeculostomy) ± 210 um in diameter. This gesture is repeated until 10 microchannels are created. The creation of these microchannels enhances the natural outflow of aqueous humor by bypassing the site of major resistance in the system. The usual duration of the ELIOS procedure is typically few minutes). The rest of the surgery does not deviate from standard phacoemulsification. | Device | Elios |
Primary outcome
Intraocular pressure (IOP)
Time frame: day 0, 7 and 30, and month 3, 6 and 12 months after surgery
This IOP measurement will be carried out using the Goldmann gold standard tonometer, in 2 measurements taken between 8am and 12am, and measured in mmHg
1 secondary outcome
Quality of life
Time frame: before and after surgery (1, 3, 6 and 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 30 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery with ELIOS laser in people with Glaucoma, run by Hôpital Privé de la Baie at 1 site in France.
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 14 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 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Ana Miguel, MD (+33787016187, myworld_ana@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (IOP) (time frame: day 0, 7 and 30, and month 3, 6 and 12 months after surgery). 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 30 Sep 2026.