Cataract Senile
Conditions
Keywords
IOL, Glistening
Brief summary
Main evaluation of glistening at least 24 Months post-IOL implantation
Detailed description
Evaluation of glistening, visual outcomes and general safety after at least 24 Months post-IOL implantation
Interventions
None listed
Sponsors
Carl Zeiss Meditec AG
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glistening Count | single study visit conducted 24 months after IOL implantation of the study eye | 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). |
| Glistening Density Evaluation | single study visit conducted 24 months after IOL implantation of the study eye | 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). |
| Glistening Grading (Miyata Classification) | single study visit conducted 24 months after IOL implantation of the study eye | 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). |
| Monocular Corrected Distance Visual Acuity (CDVA) | single study visit conducted 24 months after IOL implantation of the study eye | 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. |
Countries
China
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 29 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 73.2 Years STANDARD_DEVIATION 7 |
| Corrected distance visual acuity | 0.54 logMAR STANDARD_DEVIATION 0.21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Nationality Han Nationality | 33 Participants |
| Race/Ethnicity, Customized Nationality Other Nationality | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 33 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 33 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
None listed