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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT05716269
Eligibility Criteria:
Inclusion Criteria:
* age-related cataract patients
* Eye axis length ≤22.5mm and refraction ≥ +0.5D
* Predicted postoperative corneal astigmatism ≤0.75D
* mesopic pupil size between 3.0mm to 5.5 mm
* Preoperative angle kappa ≤ 0.5 mm
* Preoperative corneal spherical aberration \<0.5μm, high order aberration \<0.5μm
Exclusion Criteria:
* In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)
* Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
* History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis
* Patients with history of ocular trauma or prior ocular surgery including refractive procedures
* Preoperative visual acuity of worse than 0.2 logMAR in any eye.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT05716269
Study Brief:
Protocol Section:
NCT05716269