Night Driving After Trifocal Versus Monofocal IOL Implantation
- Sponsor
- Jin Yang
- Study ID
- NCT07755189
- Status
- Not Yet Recruiting
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Conditions
- Cataract
- Presbyopia Correction
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens — DEVICEAcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens
- Alcon Monofocal Intraocular Lens — DEVICEAlcon Monofocal Intraocular Lens
Study Details
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.
Key Dates
- First listed
- Aug 10, 2026
- Start date
- Aug 30, 2026
- Status verified
- Aug 2026
- Primary completion
- Aug 30, 2031
- Completion
- Aug 31, 2031
Study Design
- Enrollment
- 200 participants (estimated)
Arms
- Arm: Trifocal IOL GroupUndergo bilateral phacoemulsification and implantation of Alcon trifocal intraocular lens in both eyes
- Arm: Monofocal IOL GroupUndergo bilateral phacoemulsification and implantation of Alcon monofocal intraocular lens in both eyes
Primary Outcome Measure
VND-Q Total Score at 3 Months After Surgery [ Time Frame: 3 months after the second-eye surgery ]
Central Contacts
- Xuanqiao Lin, Doctor+8615088920668
- Lei Cai
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