Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT06760169
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06760169
Study Brief:
Protocol Section:
NCT06760169