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

A Non-interventional, Single-visit Study Focusing on the Evaluation of Glistening as Well as General Safety and Visual Outcomes With at Least 24 Months Follow-up in Patients Implanted With CT LUCIA 621P Intraocular Lenses

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

Study Overview

• Status: Completed
• Conditions: Cataract Senile

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• China
  • Hainan
    • Hainan, Hainan, China
      • Aier Eye Hospital of BoAo Hope City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients currently implanted with the CT LUCIA 621P IOL from the Aier Eye Hospital of BoAo Hope City

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glistening Evaluation		24 months post IOL Implantation
Monocular Corrected Distance Visual Acuity (CDVA)	Evaluation of the monocular Corrected Distance Visual Acuity (CDVA) a	24 months post IOL Implantation

Other Outcome Measures

Outcome Measure	Time Frame
Monocular uncorrected distance visual acuity (UDVA)	24 months post IOL Implantation
Refraction	24 months post IOL Implantation
Refraction predictability	24 months post IOL Implantation

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Estimated): December 22, 2025

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: IOL; Glistening
• Other Study ID Numbers: CT LUCIA 621P-BER-401-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No