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New lens offers hope for clearer vision in cataract patients with keratoconus

NCT ID NCT07338708

Disease control Sponsor: Azienda Ospedaliera Universitaria Integrata Verona Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a special intraocular lens (Vivity EDOF) in 10 adults who had cataracts and mild keratoconus, a condition that thins and bulges the cornea. All participants received the lens in both eyes during standard cataract surgery. The goal was to see if the lens could provide good distance, intermediate, and near vision while maintaining safety and quality of life. Participants were followed for 3 months after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Extended Depth of Focus Intraocular Lens (AcrySof IQ Vivity)
What this could lead to
If successful, this lens could offer a safe option for people with both cataracts and mild keratoconus to see clearly at multiple distances without glasses.
What could go wrong
This was a very small study (10 people) with no comparison group, so results may not apply to everyone. Mild keratoconus can progress, and the lens may not work as well in more advanced cases.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

10 people

The number who actually took part.

Started

Sep 2024

Finished

May 2025

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.

Ages

18 years and older

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 requiring bilateral cataract surgery * Mild bilateral keratoconus defined as stage 0-1 according to the ABCD classification system * Keratoconus stability defined as maximum keratometry (K) changes less than 1 diopter and maximum pachymetry reduction less than 2% within the previous 5 years * Pre-cataract spectacle distance-corrected visual acuity of 0.1 to 0.0 LogMAR (Snellen 20/25 to 20/20) * Agreement to bilateral implantation of AcrySof IQ Vivity Extended Depth of Focus intraocular lens * Willingness to undergo second-eye surgery within 7 days after first-eye procedure * Ability and willingness to attend all scheduled follow-up visits as per study protocol * Provision of written informed consent to participate in the study Exclusion Criteria: * Any ocular comorbidities other than cataract and keratoconus, or history of any disease that could affect visual results (e.g., glaucoma, retinal disorders) * Corneal opacity including any corneal scarring * Advanced or progressive keratoconus * Any previous ocular surgery other than corneal cross-linking performed at least 5 years prior to enrollment * Corneal cross-linking performed within 5 years prior to enrollment * Amblyopia * Pseudoexfoliation syndrome or zonular laxity * History of uveitis

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Conditions

The condition(s) this trial relates to.

cataract keratoconus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cataract Keratoconic subjects

Contacts and locations

Locations

  • Azienda Ospedaliera Integrata di Verona

    Verona, Verona, 37134, Italy

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