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Completed

NCT Number: NCT07297719

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

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

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Key information

Conditions

Cataract Senile

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aier Eye Hospital of BoAo Hope City

Hainan, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Glistening Evaluation

    Time frame: 24 months post IOL Implantation

  2. Monocular Corrected Distance Visual Acuity (CDVA)

    Time frame: 24 months post IOL Implantation

    Evaluation of the monocular Corrected Distance Visual Acuity (CDVA) a

Other outcomes

  1. Monocular uncorrected distance visual acuity (UDVA)

    Time frame: 24 months post IOL Implantation

  2. Refraction

    Time frame: 24 months post IOL Implantation

  3. Refraction predictability

    Time frame: 24 months post IOL Implantation

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec AG

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 22, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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