Evaluation of Glistening, Visual Outcomes and General Safety 24 Months Post-IOL Implantation

Carl Zeiss Meditec

Status: Completed

Conditions: Cataract Senile

Study type: Observational

Funder types: Industry

Identifiers

NCT07297719

CT LUCIA 621P-BER-401-25

Details and patient eligibility

About

Main evaluation of glistening at least 24 Months post-IOL implantation

Full description

Evaluation of glistening, visual outcomes and general safety after at least 24 Months post-IOL implantation

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients currently implanted with the CT LUCIA 621P IOL into the capsular bag in at least one eye and who participated in previous study "CT LUCIA 621P-BER-401-21";
2. A minimum follow-up period of 24 months after the IOL implantation of the study eye (selected as the study eye in the previous study);
3. Patients willing and capable of providing informed consent;
4. Patients willing and capable of complying with visits and procedures as defined by this protocol.

Exclusion criteria

1. Complications during cataract surgery with clinically significant impact;
2. Postoperative clinically significant corneal or retinal pathology as well as postoperative acute or chronic inflammatory ocular conditions (e.g. uveitis, iritis etc.);
3. Presence of clinically significant PCO with potential to limit the glistening evaluation;
4. IOL dislocation (the complete IOL is not stable fixated in the capsular bag);
5. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the clinical investigation;
6. Patients whose freedom is impaired by administrative or legal order.