Night Driving After Trifocal Versus Monofocal IOL Implantation

NCT07755189 | Not Yet Recruiting

• 1 other identifier: TriIOL-2026
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Presbyopia Correction

Keywords

Trifocal intraocular lens; Night driving; Visual disturbance; Dysphotopsia; Cataract surgery

Outcome Measures

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.

  3 months after the second-eye surgery

Secondary Outcomes (7)

• Glare Adaptation Item Score of the VND-Q

  3 months after the second-eye surgery

• Self-Rated Night-Driving Quality

  Baseline and 3 months after the second-eye surgery

• Self-Rated Night-Driving Speed

  Baseline and 3 months after the second-eye surgery

• Percentage of Participants Who Reduce Night Driving

  3 months after the second-eye surgery

• Distance, Intermediate, and Near Visual Acuity

  Baseline and 3 months after the second-eye surgery

Study Arms (2)

Trifocal IOL Group

Undergo bilateral phacoemulsification and implantation of Alcon trifocal intraocular lens in both eyes

Device: AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens

Monofocal IOL Group

Undergo bilateral phacoemulsification and implantation of Alcon monofocal intraocular lens in both eyes

Device: Alcon Monofocal Intraocular Lens

Interventions

AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens DEVICE

AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens

Trifocal IOL Group

Alcon Monofocal Intraocular Lens DEVICE

Alcon Monofocal Intraocular Lens

Monofocal IOL Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jin Yang: lead

Study Sites (1)

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Jin Yang

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuanqiao Lin, Doctor

CONTACT

+8615088920668; 1532483480@qq.com

Lei Cai

CONTACT

1532483480@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): August 30, 2031
• Study Completion (Estimated): August 31, 2031
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)