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 Count	Glistening count: Number of glistenings (=microvacuoles) in the illuminated field were counted by slit lamp examination at the study visit 24 months post IOL implantation of the study eye. Lower glistening counts indicate a better outcome (=fewer glistenings).	single study visit conducted 24 months after IOL implantation of the study eye
Glistening Density Evaluation	Glistening density evaluation: Number of glistenings in the illuminated field were counted by slit lamp examination at the study visit 24 months post IOL implantation of the study eye. The number of glistenings were recorded and the density of microvacuoles per square millimeter (MV/mm²) was calculated. Lower glistening density values indicate better outcome (=fewer glistenings).	single study visit conducted 24 months after IOL implantation of the study eye
Glistening Grading (Miyata Classification)	Glistening grading (Miyata classification): At the 24-month post-IOL implantation visit, the number of glistenings/microvacuoles (MV) in the illuminated field of the study eye was counted by slit-lamp examination. Glistening density was expressed as microvacuoles per square millimeter (MV/mm²) and graded using the Miyata Glistening Density Grading Scale (grades 0-3), where the minimum glistening level corresponds to grade 0 (<25 MV/mm²) and the maximum to grade 3 (101-200 MV/mm²).0 corresponds to <25 MV/mm² and grade 3 to 101-200 MV/mm². Lower Miyata grades indicate a better outcome (=fewer glistenings).	single study visit conducted 24 months after IOL implantation of the study eye
Monocular Corrected Distance Visual Acuity (CDVA)	Monocular Corrected Distance Visual Acuity (CDVA) was assessed for each study eye using a standardized visual acuity chart under photopic conditions with the subject's best refractive correction in place. CDVA was recorded in logarithm of the Minimum Angle of Resolution (logMAR), with typical values ranging from about -0.3 (approximately 20/10 Snellen acuity) to 1.0 (approximately 20/200 Snellen acuity), where lower logMAR scores indicate better vision.	single study visit conducted 24 months after IOL implantation of the study eye

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Refraction (Spherical Equivalent)	Subjective (manifest) refraction was performed under photopic conditions using standardized logarithmic visual acuity charts. For each study eye, manifest refraction was conducted to determine the best refractive correction. Sphere, cylinder, and axis were recorded, and spherical equivalent (SE) was calculated. SE values are reported in diopters (D). SE values closer to 0.00 D indicate a better refractive outcome (i.e., less residual myopia or hyperopia or astigmatism). An SE value within approximately ±0.50 D is generally considered a good refractive result.	single study visit conducted 24 months after IOL implantation of the study eye

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 (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 14, 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