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 — DEVICE
    AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens
  • Alcon Monofocal Intraocular Lens — DEVICE
    Alcon 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 Group
    Undergo bilateral phacoemulsification and implantation of Alcon trifocal intraocular lens in both eyes
  • Arm: Monofocal IOL Group
    Undergo 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

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