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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Glistening Count
研究概览
简要总结
Main evaluation of glistening at least 24 Months post-IOL implantation
详细描述
Evaluation of glistening, visual outcomes and general safety after at least 24 Months post-IOL implantation
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Glistening Count
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
Glistening Evaluation
时间窗: 24 months post IOL Implantation
Monocular Corrected Distance Visual Acuity (CDVA)
时间窗: 24 months post IOL Implantation
Evaluation of the monocular Corrected Distance Visual Acuity (CDVA) a
次要结局
未报告次要终点