ELIOS laser used during cataract surgery to treat glaucoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional, single-site procedure combines standard cataract extraction with an ab interno ELIOS excimer laser goniotomy to create ten 210 µm microchannels in the trabecular meshwork and inner wall of Schlemm’s canal using a 308 nm wavelength. The approach is a form of micro‑invasive glaucoma surgery (MIGS) intended to improve trabecular outflow and reduce intraocular pressure while avoiding the higher complication rates of traditional filtering surgery. Adult patients with visually significant cataract and open-angle glaucoma (Shaffer grade 2–4) are eligible, excluding those with advanced glaucoma or prior intraocular surgery in the intended quadrant. Outcomes will include intraocular pressure change and procedure-related safety events monitored during postoperative follow-up.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital Privé de la Baie
  Avranches, France Recruiting

Study contacts

• Study coordinator: Ana Miguel, MD
• Email: myworld_ana@hotmail.com
• Phone: +33787016187

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.