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

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 Overview

• Status: Recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Device: Surgery with ELIOS laser

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Miguel, MD; Phone Number: +33787016187; Email: myworld_ana@hotmail.com

Study Locations

• France
  • Avranches, France, 50300
    • Recruiting
    • Hôpital Privé de la Baie
    • Contact: Ana Miguel, MD; Phone Number: +332 33 50 90 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Elios

Device: Surgery 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	day 0, 7 and 30, and month 3, 6 and 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	A quality of life questionnaire : 25 questions with Likert scales	before and after surgery (1, 3, 6 and 12 months)

Collaborators and Investigators

• Sponsor: Hôpital Privé de la Baie

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): January 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: glaucoma; goniotomy; ELIOS laser; micro-invasive surgery
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Surgical Procedures, Operative
• Other Study ID Numbers: 2024-32-PDB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No