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New lens offers hope for better vision after cataract surgery

NCT ID NCT04249492

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new type of lens (EDOF) for people having cataract surgery, comparing it to a standard lens. The goal was to see if the new lens could improve vision at different distances while being safe. 250 adults aged 45 and older with cataracts took part, and the results showed no major difference in distance vision between the two lenses.

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

250 people

The number who actually took part.

Started

Feb 2020

Finished

Apr 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Cataractous eyes with no comorbidity; * Calculated IOL power is within the range of the study IOLs; * Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes; * Regular corneal astigmatism ≤1.0 D (measured by an automatic keratometer) * Clear intraocular media other than cataract; * Availability, willingness and sufficient cognitive awareness to comply with examination procedures; * Signed informed consent. Exclusion Criteria: * Age of patient \< 45 years; * Regular corneal astigmatism \>1.0 dioptres (measured by an automatic keratometer) * Irregular astigmatism; * Difficulty for cooperation (distance from their home, general health conditions); * Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse; * Subjects with AMD suspicious eyes as determined by OCT examination; * Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema; * Previous intraocular or corneal surgery; * Traumatic cataract; * History or presence of macular edema; * Instability of keratometry or biometry measurements; * Ocular hypertension or glaucoma; * Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions); * Expected complicated surgery; * Significant dry eye.

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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.

Contacts and locations

Locations

  • Asian Eye Institute

    Makati City, 1200, Philippines

  • Augen-Zentrum-Nordwest

    Ahaus, 48683, Germany

  • Augentagesklinik Rheine

    Rheine, 48429, Germany

  • Gemini Eye Clinic

    Zlín, 76001, Czechia

  • Hanusch Krankenhaus

    Vienna, 1140, Austria

  • Hospital Clínico San Carlos

    Madrid, 28040, Spain

  • Institute of Eye Surgery

    Waterford, X91 DH9W, Ireland

  • Institute of Eye Surgery - Clane

    Kildare, W91 W535, Ireland

  • Miranza IOA Madrid

    Madrid, 28003, Spain

  • Oftalvist Alicante

    Alicante, 03016, Spain

  • Smile Eyes Augen + Laserzentrum

    Leipzig, 04107, Germany

  • Universitäts-Augenklinik Heidelberg

    Heidelberg, 69120, Germany

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