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:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT02789293
Eligibility Criteria:
Inclusion Criteria:
* Open Angle Glaucoma patient (Primary Open Angle Glaucoma (POAG) including Pigmentary Glaucoma (PG) and PseudoExfoliative Glaucoma (PXF))
* Any patients without previous conventional glaucoma surgery failure (trabeculectomy, Deep Sclerectomy, Ahmed valve, drainage device implantation, cyclo cryotherapy, Diode laser cyclo-destruction)
* Subjects where the IOP is not adequately controlled with glaucoma medication, with IOP ≥ 21 mm Hg and \<30 mmHg
* No previous intraocular surgery or laser treatment during the 90 days before HIFU Day
* Age \> 18 years and \< 90 years
* Patient able and willing to complete postoperative follow-up requirements
Exclusion Criteria:
* Patient who has been diagnosed for normal tension glaucoma
* Ocular or retrobulbar tumor
* Ocular infection within 14 days prior to the HIFU procedure
* Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinically significant macular edema…)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02789293
Study Brief:
Protocol Section:
NCT02789293