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

NCT07297719 | Completed Results

• 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 (4)

• 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 Outcomes (1)

• Subjective Refraction (Spherical Equivalent)

  single study visit conducted 24 months after IOL implantation of the study eye

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

Results Point of Contact

• Title: CZM Clinical Affairs
• Organization: Carl Zeiss Meditec AG

clinicalstudies.meditec.sur@zeiss.com

+49 30 8540010

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: August 19, 2026
• Results First Posted: August 19, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)