NCT06760169 Efficacy and Safety of the ELIOS Laser in Combined Cataract and Glaucoma Surgery
| NCT ID | NCT06760169 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hôpital Privé de la Baie |
| Condition | Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2025-01-05 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 46 participants in total. It began in 2025-01-05 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06760169 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06760169 currently recruiting?
Yes, NCT06760169 is actively recruiting participants. Contact the research team at myworld_ana@hotmail.com for enrollment information.
Where is the NCT06760169 trial being conducted?
This trial is being conducted at Avranches, France.
Who is sponsoring the NCT06760169 clinical trial?
NCT06760169 is sponsored by Hôpital Privé de la Baie. The trial plans to enroll 46 participants.