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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT05516160
Eligibility Criteria:
Inclusion Criteria:
* Adult males and females, of any race
* one or both eyes with implanted intraocular monofocal lens (10 eyes) and multifocal lens (10 eyes)
* informed consent to participate in the study
* presence at scheduled follow-up visits after the procedure for a period of 24 months.
Exclusion Criteria:
* in the eye qualified for the test:
* cataract
* Fuchs dystrophy and other corneal diseases
* evidence of serious eye disease
* ophthalmic surgeries other than cataract surgery
* clinically active or past uveitis
* intraocular pressure (IOP) \>21 mmHg
* glaucoma
* retinal detachment or its suspicion in ultrasound examination of the eyeball
* systemic diseases with ocular symptoms, including diseases that may affect the function of corneal endothelial cells
* intolerance of the examination in the slit lamp or other procedures planned in the examination
* pregnancy
* mental disorders or emotional instability to an extent that does not allow the subject's informed consent in the study and presence at scheduled follow-up visits
* documented sensitivity to pharmacological agents used in the study, i.e. topical anesthetics, fluorescein, other related to the ophthalmological examination serious fatal illnesses or a patient's medical condition preventing the study from continuing for a period of 6 months
* current participation in other research programs
* therapy with oral anticoagulants
the participant may withdraw from the study at any time and for any reason without consequences and without prohibiting participation in other research projects. A participant may not return to the current study again if he or she has previously withdrawn.
Termination of participation in the study may take place in the case of:
1. decrease in visual acuity \>3 Snellen lines from baseline (\> 15 letters ETDRS, \>0.3 logMAR) in one of the eyes
2. the presence of adverse symptoms or complications associated or not with the examination, which affect the ability to see or the functioning of the body.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05516160
Study Brief:
Protocol Section:
NCT05516160