CompletedNot Applicable

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

China33 participantsStarted 2025-12-25

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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";
✓. 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);
✓. Patients willing and capable of providing informed consent;
✓. Patients willing and capable of complying with visits and procedures as defined by this protocol.

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

Glistening Evaluation

Timeframe: 24 months post IOL Implantation

Monocular Corrected Distance Visual Acuity (CDVA)

Timeframe: 24 months post IOL Implantation

NCT IDNCT07297719

SponsorCarl Zeiss Meditec AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12-31