NCT06760169Recruiting
Efficacy and Safety of the ELIOS Laser in Combined Cataract and Glaucoma Surgery
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 30 Dec 2024
- Start date
- 5 Jan 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Hôpital Privé de la Baie
- Diseases
- Glaucoma
- NCT number
- NCT06760169
What you commit to
- Study type: Interventional
- Planned participants: 46
- From 5 Jan 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of intraocular surgery, trauma, or conjunctival scarring in the quadrant intended for surgery
- Autoimmune disorder, especially collagenosis
Age
- \<18 years of age
Other
- Presence of severe systemic pathologies 2024-A01891-46\_Protocol\_V6\_21112024\_Elios Page 20 / 58
- Pregnant or breastfeeding women
- Presence of other ophthalmological pathologies (except cataracts), and exclusion of severe dry eye.
- 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
- Patient under protective supervision
- Patient not covered by a social security scheme
Who the study is looking for
- 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)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Privé de la Baie Coordinator of this site? Confirm its status | Avranches | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.