CataractTriIOLNCT07755189
Night Driving After Trifocal Versus Monofocal IOL Implantation
An observational study of Cataract and Presbyopia Correction, run by Jin Yang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cataract, Presbyopia Correction
- What is being tested?
- AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens and Alcon Monofocal Intraocular Lens
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2026to 31 Aug 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lei Cai contact
China1 site
Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
Xuanqiao Lin, 15088920668, 1532483480@qq.com
About this study
Official title: 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.
- Conditions
- Cataract, Presbyopia Correction
- Being tested
- AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens, Alcon Monofocal Intraocular Lens
- Keywords
- Trifocal intraocular lens, Night driving, Visual disturbance, Dysphotopsia, Cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcrySof IQ PanOptix TFNT00 Trifocal Intraocular LensDevice
AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens
Alcon Monofocal Intraocular LensDevice
Alcon Monofocal Intraocular Lens
| Study group | Role | What they receive |
|---|---|---|
| Trifocal IOL Group | Undergo bilateral phacoemulsification and implantation of Alcon trifocal intraocular lens in both eyes Receives: Device: AcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens | |
| Monofocal IOL Group | Undergo bilateral phacoemulsification and implantation of Alcon monofocal intraocular lens in both eyes Receives: Device: Alcon Monofocal Intraocular Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after the second-eye surgery
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months after the second-eye surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Aug 2031 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Yang, Eye & ENT Hospital of Fudan University
- Investigators
- Jin Yang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755189
- Sponsor's protocol ID
- TriIOL-2026
- Acronym
- TriIOL
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Night-Driving Visual Quality and Visual Disturbances After Bilateral Trifocal Versus Monofocal Intraocular Lens Implantation: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07755189
- Acronym / sponsor ID
- TriIOL / TriIOL-2026
- Conditions
- Cataract, Presbyopia Correction
- Keywords
- Trifocal intraocular lens, Night driving, Visual disturbance, Dysphotopsia, Cataract surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jin YangUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2031 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trifocal IOL Group | – | Device: AcrySof IQ PanOptix TFNT00 Trifocal Intraocular LensUndergo bilateral phacoemulsification and implantation of Alcon trifocal intraocular lens in both eyes |
| Monofocal IOL Group | – | Device: Alcon Monofocal Intraocular LensUndergo bilateral phacoemulsification and implantation of Alcon monofocal intraocular lens in both eyes |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcrySof IQ PanOptix TFNT00 Trifocal Intraocular LensAcrySof IQ PanOptix TFNT00 Trifocal Intraocular Lens | Device | Trifocal IOL Group |
| Alcon Monofocal Intraocular LensAlcon Monofocal Intraocular Lens | Device | Monofocal IOL Group |
Primary outcome
VND-Q Total Score at 3 Months After Surgery
Time frame: 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.
7 secondary outcomes
Glare Adaptation Item Score of the VND-Q
Time frame: 3 months after the second-eye surgery
Self-Rated Night-Driving Quality
Time frame: Baseline and 3 months after the second-eye surgery
Self-Rated Night-Driving Speed
Time frame: Baseline and 3 months after the second-eye surgery
Percentage of Participants Who Reduce Night Driving
Time frame: 3 months after the second-eye surgery
Distance, Intermediate, and Near Visual Acuity
Time frame: Baseline and 3 months after the second-eye surgery
Whole-Eye Aberrations
Time frame: Baseline and 3 months after the second-eye surgery
Visual Disturbance Questionnaire Score
Time frame: Baseline and 3 months after the second-eye surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Cataract
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
Aphakia, Cataract
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingObservational study
Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
Cataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Cai contact
Jin Yang principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Presbyopia Correction, run by Jin Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuanqiao Lin, Doctor (+8615088920668, 1532483480@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VND-Q Total Score at 3 Months After Surgery (time frame: 3 months after the second-eye surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.