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
Qualifiers
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 design
Treatments tested in this trial
- AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens
- Alcon Monofocal Intraocular Lens
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jin Yang
Lead sponsor
Eye & ENT Hospital of Fudan University
Sponsor institution
Source ClinicalTrials.gov