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Can trifocal lens implants keep night driving safe and clear?

NCT ID NCT07755189

Knowledge-focused Sponsor: Jin Yang Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

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

18 to 85 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Eye and ENT hospital of Fudan University

    Shanghai, Shanghai Municipality, 200000, China

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