Cataract, Presbyopia Correction
Conditions
Keywords
Trifocal intraocular lens, Night driving, Visual disturbance, Dysphotopsia, Cataract surgery
Brief 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.
Interventions
DEVICEAcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens
AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens
DEVICEAlcon Monofocal Intraocular Lens
Alcon Monofocal Intraocular Lens
Sponsors
Jin Yang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Stable night-driving behavior during the previous 3 months, with night driving occurring at least twice per month. * Lens Opacities Classification System III nuclear opalescence grade of 4 or lower in both eyes. * Expected intraocular lens power between +10.0 D and +36.0 D, inclusive, in both eyes. * Ability to understand the purpose and procedures of the study and independently complete the VND-Q and visual quality questionnaires. * Willingness to provide written informed consent and complete the scheduled postoperative follow-up visits.
Exclusion criteria
* 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. * A high risk of zonular rupture or an contraindication to in-the-bag intraocular lens implantation, including zonular weakness, zonular dialysis, lens subluxation or dislocation, pseudoexfoliation syndrome, Marfan syndrome, posterior capsule rupture, or cyclodialysis. Severe or unstable systemic disease, including systemic lupus erythematosus or Sjögren syndrome. * Use of medication judged by the investigator to increase surgical risk or affect visual function, including amiodarone, chlorpromazine, ethambutol, digitalis, or chloroquine. * Requirement for a combined ocular procedure, including limbal relaxing incisions, intraocular drug injection, retinal laser treatment, or another combined procedure judged inappropriate by the investigator. * Severe anxiety, depression, or another significant psychiatric disorder. * Any other condition judged by the investigator to make participation inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VND-Q Total Score at 3 Months After Surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glare Adaptation Item Score of the VND-Q | 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. |
| Self-Rated Night-Driving Quality | 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. |
| Self-Rated Night-Driving Speed | 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. |
| Percentage of Participants Who Reduce Night Driving | 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. |
| Distance, Intermediate, and Near Visual Acuity | 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. |
| Whole-Eye Aberrations | 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. |
| Visual Disturbance Questionnaire Score | 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. |
Countries
China
Contacts
CONTACTLei Cai
PRINCIPAL_INVESTIGATORJin Yang
Fudan University
CONTACTXuanqiao Lin, Doctor
Outcome results
None listed