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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT04249492
Eligibility Criteria:
Inclusion Criteria:
* Cataractous eyes with no comorbidity;
* Calculated IOL power is within the range of the study IOLs;
* Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes;
* Regular corneal astigmatism ≤1.0 D (measured by an automatic keratometer)
* Clear intraocular media other than cataract;
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
* Signed informed consent.
Exclusion Criteria:
* Age of patient \< 45 years;
* Regular corneal astigmatism \>1.0 dioptres (measured by an automatic keratometer)
* Irregular astigmatism;
* Difficulty for cooperation (distance from their home, general health conditions);
* Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
* Subjects with AMD suspicious eyes as determined by OCT examination;
* Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema;
* Previous intraocular or corneal surgery;
* Traumatic cataract;
* History or presence of macular edema;
* Instability of keratometry or biometry measurements;
* Ocular hypertension or glaucoma;
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
* Expected complicated surgery;
* Significant dry eye.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT04249492
Study Brief:
Protocol Section:
NCT04249492