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RecruitingNCT06760169ELIOSUpdated Sep 30, 2026

Efficacy and Safety of the ELIOS Laser in Combined Cataract and Glaucoma Surgery

An interventional study of Surgery with ELIOS laser in Glaucoma, sponsored by Hôpital Privé de la Baie. Recruiting at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Hôpital Privé de la Baie · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.). 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.

02

Conditions studied

  • Glaucoma

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Keywords

  • glaucoma
  • ELIOS laser
  • micro-invasive surgery
  • goniotomy
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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".
  • 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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Elios

    Device: Surgery with ELIOS laser

Interventions

  • DeviceSurgery with ELIOS laser

    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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: before and after surgery (1, 3, 6 and 12 months)

06

Study locations

1 of 1 sites recruiting
  • Hôpital Privé de la Baie
    Avranches, 50300, France
    • Ana Miguel, MD · Contact · +332 33 50 90 90
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06760169
Lead sponsor
Hôpital Privé de la Baie
Responsible party
Sponsor
First posted
Jan 6, 2025
Start date
Jan 5, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Feb 28, 2028 (estimated)
Last update
Sep 30, 2026

Study contacts

Ana Miguel, MD
Contact
myworld_ana@hotmail.com
+33787016187

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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