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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT06229756
Eligibility Criteria:
Inclusion Criteria:
* Patients 50 years old or more submitted to bilateral cataract surgery and implanted with Asqelio EDOF toric IOL, with cylinder value of 0.0 D.
* Patients signing informed consent
* Transparent media except for the cataracts
* Potential postoperatoria visual acuity of 20/25 or better
Exclusion Criteria:
* Preoperative corneal astigmatism greater than 1.00D
* Patients who do not provide informed consent
* Patients who do not understand the study procedure
* Previous corneal surgery or trauma
* Irregular cornea (e.g. keratoconus)
* Choroidal hemorrhage
* Microphtalmos
* Severe corneal dystrophy
* Uncontrolled or medically controlled glaucoma
* Clinically significant macular changes
* Concomitant severe eye disease
* Non-age-related cataract
* Severe optic nerve atrophy
* Diabetic retinopathy
* Proliferative diabetic retinopathy
* Amblyopia
* Extremely shallow anterior camera
* Severe chronic uveítis
* Pregnant or nursing
* Rubella
* Mature/dense cataract that makes it difficult to examine the fundus preoperatively.
* Previous retinal detachment
* Concurrent participation in other research with drugs or clinical devices
* Expect to require another eye surgery during the study period
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06229756
Study Brief:
Protocol Section:
NCT06229756