ELIOS laser used during cataract surgery to treat glaucoma
Efficacy and Safety of the ELIOS Laser in Combined Cataract and Glaucoma Surgery
This trial will test whether using the ELIOS excimer laser at the time of cataract surgery lowers eye pressure in adults with early to moderate open-angle glaucoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hôpital Privé de la Baie Academic / other |
| Locations | 1 site (Avranches) |
| Trial ID | NCT06760169 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with visually significant cataract and early to moderate primary or certain secondary open-angle glaucomas who have open iridocorneal angles and no history of intraocular surgery in the operative quadrant.
Not a fit: Patients with advanced glaucoma (visual field mean deviation worse than −12 dB), angle‑closure glaucoma, severe ocular comorbidities, previous intraocular surgery in the target quadrant, or very poor vision are unlikely to benefit.
Why it matters
Potential benefit: If successful, the procedure could lower eye pressure and reduce the need for glaucoma medications while carrying fewer risks than more invasive glaucoma surgeries.
How similar studies have performed: Micro‑invasive glaucoma surgeries, including various goniotomy techniques, have shown benefit in lowering intraocular pressure, while the ELIOS excimer laser approach is newer with limited but emerging published results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Avranches
- Hôpital Privé de la Baie — Avranches, France (Recruiting)
Study contacts
- Study coordinator: Ana Miguel, MD
- Email: myworld_ana@hotmail.com
- Phone: +33787016187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.