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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT03276104
Eligibility Criteria:
Inclusion Criteria:
* IOL inside the capsule ("in-the-bag")
* Late dislocation (more than 6 months after cataract surgery)
* IOL visible in the pupillary area in the supine position and hence possible to perform surgery with an anterior approach
* Eligibility for both operation methods
* Ability to cooperate fairly well during the examinations
* Willing to participate in the study, e.g. willingness to participate at all control visits
Exclusion Criteria:
* IOL designs that cannot be repositioned with a suture loop, such as plate-haptic IOLs without holes in the peripheral part
* Eyes with especially thin sclera
* Active uveitis or pronounced iris pathology
* Eyes with previously performed Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
* Totally dislocated IOL into the posterior segment of the eye requiring pars plana vitrectomy
* Eyes that prior to cataract extraction had a subluxated lens in need of surgery with a Cionni capsular tension ring (e.g. patients with Marfan syndrome and ectopia lentis)
* Cases requiring a change in refraction. Risk of severe anisometropia
* Patients unable to lie in supine position for surgery in local anesthesia, e.g. severe chronic obstructive pulmonary disease and severe heart failure
* Patients using anticoagulants that cannot be discontinued
For patients with dislocated IOLs in both eyes during the study period, only the first operated eye will be included. Patients without prospects of improvement in vision will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03276104
Study Brief:
Protocol Section:
NCT03276104