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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT03633851
Eligibility Criteria:
Inclusion Criteria:
* Bilateral cataract.
* Age 21 and older.
* Written informed consent to sequential bilateral surgery and participation in the study.
* Preoperative pupil size greater than or equal to 5.0 mm in the study eye.
* IOL power as predicted by biometry ranging from 6.0 D to 30.0 D in both eyes.
* Regular corneal astigmatism according to Orbscan topography.
* Postoperative corneal astigmatism between 0.90 D and 1.40 D in both eyes, as predicted by the Bausch + Lomb Toric Calculator (https://envista.toriccalculator.com).
Exclusion Criteria:
* Ocular comorbidity (corneal scars, amblyopia, retina, or optic nerve disease) that may reduce postoperative CDVA
* Reduced zonular or capsular stability (e.g. Marfan syndrome, previous eye trauma)
* Irregular corneal astigmatism on Orbscan topography
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03633851
Study Brief:
Protocol Section:
NCT03633851