Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, 200000, China
NCT Number: NCT07755189
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.
Trial opening soon.
Get Notified18 year–85 year
All sexes
Observational
Shanghai, Shanghai Municipality, 200000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Severe or unstable systemic disease, including systemic lupus erythematosus or Sjögren syndrome.
AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens
Alcon Monofocal Intraocular Lens
Time frame: 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.
Time frame: 3 months after the second-eye surgery
Score of the VND-Q item assessing difficulty adapting to glare from oncoming vehicle headlights. A higher score indicates greater difficulty with glare adaptation.
Time frame: Baseline and 3 months after the second-eye surgery
Participant-reported night-driving quality assessed using a study-specific 5-point rating scale. Higher or lower scores will be interpreted according to the predefined questionnaire scoring system.
Time frame: Baseline and 3 months after the second-eye surgery
Participant-reported assessment of usual night-driving speed using a study-specific 5-point rating scale.
Time frame: 3 months after the second-eye surgery
The number and percentage of participants reporting that they reduced their night-driving frequency after surgery, based on a binary yes-or-no questionnaire item.
Time frame: Baseline and 3 months after the second-eye surgery
Uncorrected distance visual acuity, uncorrected intermediate visual acuity, uncorrected near visual acuity, corrected distance visual acuity, distance-corrected intermediate visual acuity, and distance-corrected near visual acuity will be measured using logarithm of the minimum angle of resolution units. Testing distances will be 4 m for distance, 60 cm for intermediate, and 40 cm for near vision.
Time frame: Baseline and 3 months after the second-eye surgery
Whole-eye optical aberrations measured using the same wavefront aberrometry device and standardized testing parameters for all participants.
Time frame: Baseline and 3 months after the second-eye surgery
Participant-reported frequency or severity of glare, halos, starbursts, and other visual disturbances assessed using a standardized visual quality questionnaire.
Contact information is provided by the study sponsor or research team.
Jin Yang
Other
Night-Driving Visual Quality and Visual Disturbances After Bilateral Trifocal Versus Monofocal Intraocular Lens Implantation: A Prospective Observational Cohort Study
Acronym: TriIOL
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