A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 7
- 主要终点
- Mean monocular best corrected distance visual acuity (BCDVA)
研究概览
简要总结
The purpose of this post-market clinical follow-up (PMCF) study is to describe the long-term safety and performance of AcrySof Single-Piece and AcrySof Multi-Piece monofocal intraocular lenses (IOLs).
详细描述
The study includes a retrospective chart review for pre-operative, operative, and post-operative data collection, and a prospective, standard-of-care visit to collect study endpoints.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is implanted with one of the study IOL models between 3 and 5 years previously.
- •Subject follow-up is expected to be possible during the duration of the study.
- •Subject or legally authorized representative must be able to understand and sign the IRB/EC approved Informed Consent form. Minor subjects will complete an Assent Form.
- •Documented medical history and required pre-operative baseline information is available for retrospective data collection.
排除标准
- •Subject is participating in a separate investigational drug or device study.
- •Pregnancy at the time of enrollment.
结局指标
主要结局
Mean monocular best corrected distance visual acuity (BCDVA)
时间窗: Up to 3 to 5 years post operative
Retrospectively, the subject's medical records will be reviewed for assessments of BCDVA. Prospectively, visual acuity will be assessed for each eye individually with correction in place using letter charts placed at a distance of 6 meters (or 4 meters adjusted for infinity) from the subject. BCDVA will be reported in logarithm minimum angle of resolution (logMAR), where a logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight) and lower logMAR values indicate better visual acuity.
Rate of protocol-specified ocular adverse events
时间窗: Up to 3 to 5 years post operative
The subject's medical records will be reviewed for medical conditions. Medical conditions that started after initial exposure to the study model IOLs will be captured as adverse events. The following adverse events are pre-specified for this outcome measure: * Cystoid macular edema (CME) * Hypopyon * Endophthalmitis * Lens dislocation * Pupillary block * Retinal detachment * Secondary surgical interventions
次要结局
- Rate of additional adverse events - Ocular(Up to 3-5 years postoperative)
- Mean manifest refraction - Axis(Up to 3-5 years postoperative)
- Mean manifest refraction - Cylinder(Up to 3-5 years postoperative)
- Mean monocular uncorrected distance visual acuity (UCDVA)(Up to 3-5 years postoperative)
- Manifest refraction spherical equivalent (MRSE)(Up to 3-5 years postoperative)
- Rate of posterior capsulotomies(Up to 3-5 years postoperative)
- Mean manifest refraction - Sphere(Up to 3-5 years postoperative)
- Rate of device deficiencies(Up to 3-5 years postoperative)