Evaluation of Visual Adaptation and Optical Performance in Patients With Bilateral Multifocal or Mix-and-Match Intraocular Lens Implantation: A Longitudinal Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Subjective Visual Adaptation Score (Multifocal Motor Adaptation Questionnaire, MMAQ)
研究概览
简要总结
This longitudinal observational study aims to evaluate long-term visual adaptation trajectories, optical quality, and patient-reported outcomes in age-related cataract patients following bilateral implantation of multifocal or mix-and-match intraocular lenses (IOLs). Patients will be followed up longitudinally after surgery to systematically assess visual performance and quality of life.
详细描述
Multifocal and mix-and-match intraocular lens (IOL) implantation strategies have been widely adopted to restore full-range vision after cataract surgery. However, patients often experience varying rates and trajectories of neuroadaptation to optical phenomena such as glare and halos.
This study prospectively observational tracks age-related cataract patients undergoing bilateral IOL implantation (homogeneous or mix-and-match combinations). Postoperative evaluations are systematically conducted across key follow-up time points (ranging from 1 week up to 6 months postoperatively). Primary evaluations involve standard ophthalmological measurements alongside validated visual questionnaires (including the MMAQ) to capture longitudinal adaptation patterns, spectacle independence, and overall visual satisfaction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older with age-related cataract requiring bilateral phacoemulsification and intraocular lens (IOL) implantation
- •Corneal astigmatism less than 0.75 D
- •Good general health and willing to complete all postoperative follow-up visits
- •Signed written informed consent
排除标准
- •Previous ocular surgery or ocular trauma
- •Coexisting ocular diseases affecting visual potential, such as corneal opacity, glaucoma, macular degeneration, or diabetic retinopathy
- •Intraoperative or postoperative complications (e.g., posterior capsule rupture)
- •Systemic diseases that may interfere with visual outcomes or follow-up compliance
结局指标
主要结局
Subjective Visual Adaptation Score (Multifocal Motor Adaptation Questionnaire, MMAQ)
时间窗: Preoperatively, and postoperatively at 1 week, 1 month, 3 months, and 6 months
Assessed using the Multifocal Motor Adaptation Questionnaire (MMAQ), a custom-designed questionnaire developed by the research team to measure subjective visual adaptation and symptoms in patients following intraocular lens implantation. Scores range from 0 to 100, with higher scores indicating higher levels of visual adaptation and satisfaction.
次要结局
- Total High-Order Aberrations (HOAs)(Postoperatively at 1 month, 3 months, and 6 months)
- Defocus Curve(Postoperatively at 1 month, 3 months, and 6 months)
- Uncorrected Binocular Distance Visual Acuity (UDBVA)(Preoperatively, and postoperatively at ,1 month, 3 months, and 6 months)
- Spherical Aberration(Postoperative 1 month, 3 months, and 6 months)
- Horizontal Coma(Postoperative 1 month, 3 months, and 6 months)
- Vertical Coma(Postoperative 1 month, 3 months, and 6 months)
- Total Coma RMS(Postoperative 1 month, 3 months, and 6 months)
- Uncorrected Binocular Intermediate Visual Acuity (UIBVA)(Preoperatively, and postoperatively at 1 month, 3 months, and 6 months)
- Uncorrected Bincorrected Near Visual Acuity (UNBVA)(Preoperatively, and postoperatively at 1 month, 3 months, and 6 months)
- Contrast Sensitivity(Postoperative 1 month, 3 months, and 6 months)
研究者
ChaoQu
Professor, Department of Ophthalmology
Sichuan Academy of Medical Sciences