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 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT06533995
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years old patients, male and female
* Previous diagnosis of cataract requiring surgery
* Wishing to participate in the study and able to sign the ICF
* No topic ophthalmic medication, including lubricating eyedrops administration for at least 4 days before screening visit.
Exclusion Criteria:
* Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g.rheumatic disease)
* Previous participation on this study for the fellow eye
* Increased risk of complicated cataract surgery according to the investigator assessment (for example presence of dilation less than 6 mm, pupil decentration, pseudoexfoliation, areas of iris atrophy, sublussation or lussation of the lens, complete cataract, sac instability, iridodonesis, systemic disease limiting intraoperative patient cooperation)
* Coexisting corneal diseases
* Past or active conjunctivitis - any type
* Past ocular surface burns
* Keratinization of the eyelid margin
* Sjogren syndrome
* History of corneal trauma
* Pregnant and lactating women
* Inability to self-administer study medications
* Know allergic sensitivity to any of the devices ingredients, or any other type of allergy
* Participation in a clinical trial during the 3 months prior to the beginning of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06533995
Study Brief:
Protocol Section:
NCT06533995