Night Driving After Trifocal Versus Monofocal IOL Implantation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorJin Yang
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adults aged 18 to 85 years with bilateral cataract who are scheduled to undergo bilateral phacoemulsification and in-the-bag implantation of either the same model of Alcon trifocal intraocular lens in both eyes or the same model of Alcon monofocal intraocular lens in both eyes. Participants must have a valid driving license and a stable history of night driving during the 3 months before enrollment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens
DeviceAcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens
Alcon Monofocal Intraocular Lens
DeviceAlcon Monofocal Intraocular Lens
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Trifocal IOL Group1 intervention
Group B: Monofocal IOL Group1 intervention
Trial outcomes
Primary outcomes
1
VND-Q Total Score at 3 Months After 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 surgerySecondary outcomes
1
Glare Adaptation Item Score of the VND-Q
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
3 months after the second-eye surgery2
Self-Rated Night-Driving Quality
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 surgery3
Self-Rated Night-Driving Speed
Participant-reported assessment of usual night-driving speed using a study-specific 5-point rating scale.
Time frame
Baseline and 3 months after the second-eye surgery4
Percentage of Participants Who Reduce Night Driving
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
3 months after the second-eye surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Jin Yang
Lead sponsor
Eye & ENT Hospital of Fudan University
Sponsor institution
Source ClinicalTrials.gov
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