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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT05790993
Eligibility Criteria:
Inclusion Criteria:
* Patients 50 years or older submitted to cataract surgery and implanted with Asqelio trifocal TFLIO130C IOL using the BIOLI-D delivery system.
* Patients submitted to bilateral cataract surgery.
* Transparent ocular media, other than the bilateral cataract.
Exclusion Criteria:
* Preoperatory corneal astigmatism greater than 0.75D
* Corneal surgery or trauma prior to cataract surgery Irregular cornea
* Choroidal hemorrhage
* Microftalmos Severe corneal dystrophy
* Uncontrolled or medically controlled glaucoma
* Clinically significant macular changes
* Concomitant ocular disease
* Not age-related cataract
* Severe optic nerve atrophy
* Diabetic retinopathy
* Proliferative diabetic retinopathy
* Amblyopia
* Extremelly shallow anterior chamber
* Severe chronic uveitis
* Rubella
* Mature/dense cataract difficulting fundas assessment preoperatively
* Prior retinal detachment
* Concurrent participation in another investigation with medication or clinical devices
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT05790993
Study Brief:
Protocol Section:
NCT05790993