An observational study in Cataract and Presbyopia Correction, sponsored by Jin Yang. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Jin Yang · Observational
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 200 is above the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →Jin Yang is the lead sponsor of 7 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Severe or unstable systemic disease, including systemic lupus erythematosus or Sjögren syndrome.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Undergo bilateral phacoemulsification and implantation of Alcon trifocal intraocular lens in both eyes
Device: AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens
Undergo bilateral phacoemulsification and implantation of Alcon monofocal intraocular lens in both eyes
Device: Alcon Monofocal Intraocular Lens
AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens
Alcon Monofocal Intraocular Lens
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 surgery
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 surgery
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 surgery
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 surgery
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 surgery
Distance, Intermediate, and Near Visual Acuity
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.
Time frame: Baseline and 3 months after the second-eye surgery
Whole-Eye Aberrations
Whole-eye optical aberrations measured using the same wavefront aberrometry device and standardized testing parameters for all participants.
Time frame: Baseline and 3 months after the second-eye surgery
Visual Disturbance Questionnaire Score
Participant-reported frequency or severity of glare, halos, starbursts, and other visual disturbances assessed using a standardized visual quality questionnaire.
Time frame: Baseline and 3 months after the second-eye surgery
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Aug 2031, 60 months later.
Of 167 non-industry observational studies under Cataract, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's planned 60 months is above that.
Counting every sponsor, half of 234 studies reached it within 16 months; a quarter within 9 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Jin Yang