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NCT07755189

Night Driving After Trifocal Versus Monofocal IOL Implantation

Sponsor: Jin Yang

View on ClinicalTrials.gov

Summary

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.

Official title: Night-Driving Visual Quality and Visual Disturbances After Bilateral Trifocal Versus Monofocal Intraocular Lens Implantation: A Prospective Observational Cohort Study

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2026-08-30

Completion Date

2031-08-31

Last Updated

2026-08-10

Healthy Volunteers

No

Interventions

DEVICE

AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens

AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens

DEVICE

Alcon Monofocal Intraocular Lens

Alcon Monofocal Intraocular Lens

Locations (1)

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, China