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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01752218
Eligibility Criteria:
Inclusion Criteria:
* Clear corneal media
* Patients must be at least 40 years of age
* mono- or bilateral Cataract with uncorrected distance visual acuity (UCDVA)
* 0.63 or glare sensitivity
* Vectorial averaged astigmatism of keratometric and topographic astigmatism:
* 1.0 D and ≤ 2.0 D
* Patients must have read, understood the Patient Information and signed the informed consent form
* Patients are willing and able to return for follow-up examinations
Exclusion Criteria:
* The maximum K- value may not exceed 60D, the minimal value may not be smaller than 37D
* Pachymetry does not include examination results at an radius of 4.25 mm
* Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
* Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
* Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
* Manifest Glaucoma
* Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
* Known sensitivity to planned concomitant medications
* Patients regularly taking medicines that could influence the result of the treatment respectively the vision
* Patients with disorders of the ocular muscle, such as nystagmus or strabismus
* Patients with keratoconus, keratectasia or other irregular cornea changes
* Patients with connective tissue weakness
* Patients who are blind on one eye
* Subjects who are immune compromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis, collagenosis and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study.
* Abnormal examination results from slit lamp, fundus examination or IOL Master, age related changes are acceptable
* Patients with eye diseases which decreases the visual acuity such as macular degeneration, macular edema, proliferative diabetic Retinopathy
* Abnormal examination results from Topography, age related changes are acceptable
* Patients who are pregnant or nursing
* Patients with concentration disorders, epilepsy and other complicating diseases
* Patients who are participating in another clinical study 30 days before
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01752218
Study Brief:
Protocol Section:
NCT01752218