Can trifocal lens implants keep night driving safe and clear?
NCT ID NCT07755189
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This study follows adults having cataract surgery who choose either a trifocal or monofocal intraocular lens implant. It asks whether one type leads to more difficulty or visual disturbances, like glare or halos, when driving at night. Participants must be licensed drivers with regular night-driving habits. The main measure is a questionnaire about night-driving difficulty three months after surgery, with additional tests of vision and glare adaptation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Trifocal intraocular lens (AcrySof IQ PanOptix TFNT00) or monofocal intraocular lens (Alcon)
- What this could lead to
- If trifocal lenses prove as safe for night driving as monofocal ones, more cataract patients could choose them without worrying about glare or halos.
- What could go wrong
- This is an observational study, not a randomized trial, so results may be influenced by patient choice. Also, outcomes rely on self-reported questionnaires, which can be subjective.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, 200000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Eye drops may shield the cornea after cataract surgery
- A simple blood draw might reveal hidden eye lymphoma
- Can a new lens make glasses obsolete after cataract surgery?
- Can a new lens design sharpen vision after macular surgery?