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Night Driving After Trifocal Versus Monofocal IOL Implantation (TriIOL)

5 augustus 2026 bijgewerkt door: Jin Yang

Night-Driving Visual Quality and Visual Disturbances After Bilateral Trifocal Versus Monofocal Intraocular Lens Implantation: A Prospective Observational Cohort Study

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

200

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Xuanqiao Lin, Doctor
  • Telefoonnummer: +8615088920668
  • E-mail: 1532483480@qq.com

Studie Locaties

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Eye and ENT Hospital of Fudan University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Trifocal IOL Group
Undergo bilateral phacoemulsification and implantation of Alcon trifocal intraocular lens in both eyes
Apparaat: AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens
AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens
Monofocal IOL Group
Undergo bilateral phacoemulsification and implantation of Alcon monofocal intraocular lens in both eyes
Apparaat: Alcon Monofocal Intraocular Lens
Alcon Monofocal Intraocular Lens

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
VND-Q Total Score at 3 Months After Surgery
Tijdsspanne: 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.
3 months after the second-eye surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Glare Adaptation Item Score of the VND-Q
Tijdsspanne: 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.
3 months after the second-eye surgery
Self-Rated Night-Driving Quality
Tijdsspanne: 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.
Baseline and 3 months after the second-eye surgery
Self-Rated Night-Driving Speed
Tijdsspanne: 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.
Baseline and 3 months after the second-eye surgery
Percentage of Participants Who Reduce Night Driving
Tijdsspanne: 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.
3 months after the second-eye surgery
Distance, Intermediate, and Near Visual Acuity
Tijdsspanne: 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.
Baseline and 3 months after the second-eye surgery
Whole-Eye Aberrations
Tijdsspanne: 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.
Baseline and 3 months after the second-eye surgery
Visual Disturbance Questionnaire Score
Tijdsspanne: 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.
Baseline and 3 months after the second-eye surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Jin Yang

Onderzoekers

  • Hoofdonderzoeker: Jin Yang, Fudan University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 augustus 2026

Primaire voltooiing (Geschat)

30 augustus 2031

Studie voltooiing (Geschat)

31 augustus 2031

Studieregistratiedata

Eerst ingediend

5 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 augustus 2026

Eerst geplaatst (Werkelijk)

10 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

5 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TriIOL-2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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