Night-Driving Visual Quality and Visual Disturbances After Bilateral Trifocal Versus Monofocal Intraocular Lens Implantation: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- VND-Q Total Score at 3 Months After Surgery
研究概览
简要总结
This prospective observational cohort study will compare night-driving visual difficulty and visual disturbances after bilateral implantation of an Alcon trifocal intraocular lens or an Alcon monofocal intraocular lens in adults undergoing cataract surgery. The type of intraocular lens will be selected by each participant and the treating ophthalmologist as part of routine clinical care, and will not be assigned by the investigators.
Eligible participants must have a valid motor vehicle driving license and a stable history of night driving during the previous 3 months. The primary outcome will be the total score of the Visual Function and Night Driving Questionnaire (VND-Q) at 3 months postoperatively. Secondary assessments will include glare adaptation, self-rated night-driving quality and driving speed, changes in night-driving behavior, visual disturbances, distance, intermediate and near visual acuity, contrast sensitivity, whole-eye aberrations, pupil diameter, defocus performance, reading speed, spectacle independence, and participant 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 85 years.
- •Scheduled to undergo bilateral phacoemulsification with in-the-bag intraocular lens implantation.
- •Both eyes scheduled to receive the same type and model of either an Alcon trifocal intraocular lens or an Alcon monofocal intraocular lens.
- •Possession of a valid motor vehicle driving license.
- •Stable night-driving behavior during the previous 3 months, with night driving occurring at least twice per month.
- •Lens Opacities Classification System III nuclear opalescence grade of 4 or lower in both eyes.
- •Expected intraocular lens power between +10.0 D and +36.0 D, inclusive, in both eyes.
- •Ability to understand the purpose and procedures of the study and independently complete the VND-Q and visual quality questionnaires.
- •Willingness to provide written informed consent and complete the scheduled postoperative follow-up visits.
排除标准
- •Corneal endothelial cell density below 1,500 cells/mm² in either eye.
- •History of ocular trauma affecting visual function, previous intraocular surgery, or previous corneal refractive surgery in either eye.
- •Strabismus, amblyopia, or nystagmus in either eye.
- •Any ocular disease that may affect postoperative visual acuity, contrast sensitivity, mesopic visual function, or questionnaire assessment, including but not limited to irregular corneal astigmatism, corneal scar, corneal degeneration, keratoconus, keratitis, corneal dystrophy, uveitis, severe iris atrophy, intraoperative floppy iris syndrome, microphthalmos, macrophthalmos, color vision deficiency, active ocular inflammation, advanced glaucoma or uncontrolled intraocular pressure, macular disease, retinal pigment epithelial disease, diabetic retinopathy, retinal detachment, choroidal detachment, or optic atrophy.
- •A high risk of zonular rupture or an contraindication to in-the-bag intraocular lens implantation, including zonular weakness, zonular dialysis, lens subluxation or dislocation, pseudoexfoliation syndrome, Marfan syndrome, posterior capsule rupture, or cyclodialysis.
- •Severe or unstable systemic disease, including systemic lupus erythematosus or Sjögren syndrome.
- •Use of medication judged by the investigator to increase surgical risk or affect visual function, including amiodarone, chlorpromazine, ethambutol, digitalis, or chloroquine.
- •Requirement for a combined ocular procedure, including limbal relaxing incisions, intraocular drug injection, retinal laser treatment, or another combined procedure judged inappropriate by the investigator.
- •Severe anxiety, depression, or another significant psychiatric disorder.
- •Any other condition judged by the investigator to make participation inappropriate.
研究组 & 干预措施
Trifocal IOL Group
Undergo bilateral phacoemulsification and implantation of Alcon trifocal intraocular lens in both eyes
干预措施: AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens (Device)
Monofocal IOL Group
Undergo bilateral phacoemulsification and implantation of Alcon monofocal intraocular lens in both eyes
干预措施: Alcon Monofocal Intraocular Lens (Device)
结局指标
主要结局
VND-Q Total Score at 3 Months After Surgery
时间窗: 3 months after the second-eye surgery
The Visual Function and Night Driving Questionnaire (VND-Q) consists of 9 items. Each item is rated on a 5-point Likert scale from 1, indicating no difficulty, to 5, indicating extreme difficulty. The total score ranges from 9 to 45, with higher scores indicating greater subjective difficulty during night driving.
次要结局
- Glare Adaptation Item Score of the VND-Q(3 months after the second-eye surgery)
- Self-Rated Night-Driving Quality(Baseline and 3 months after the second-eye surgery)
- Self-Rated Night-Driving Speed(Baseline and 3 months after the second-eye surgery)
- Percentage of Participants Who Reduce Night Driving(3 months after the second-eye surgery)
- Distance, Intermediate, and Near Visual Acuity(Baseline and 3 months after the second-eye surgery)
- Whole-Eye Aberrations(Baseline and 3 months after the second-eye surgery)
- Visual Disturbance Questionnaire Score(Baseline and 3 months after the second-eye surgery)
研究者
Jin Yang
Chief Physician
Eye & ENT Hospital of Fudan University