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

NCT07297719 | Completed

• 1 other identifier: CT LUCIA 621P-BER-401-25
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract Senile

Keywords

IOL; Glistening

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Monocular uncorrected distance visual acuity (UDVA)

  24 months post IOL Implantation

• Refraction

  24 months post IOL Implantation

• Refraction predictability

  24 months post IOL Implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

Study Sites (1)

Aier Eye Hospital of BoAo Hope City

Hainan, Hainan, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: December 25, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)