Eye lens implant aims to free people from reading glasses

NCT ID NCT04632784

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 15, 2026 · Last updated Oct 16, 2026 · Updated 1 time

Summary

Researchers are testing a multifocal intraocular lens called Artiflex Presbyopic (Artiplus) to correct presbyopia in people who still have their natural lenses. The trial enrolls adults with presbyopia and refractive errors who want to see clearly at near and far distances without glasses. The lens is surgically attached to the iris and aims to improve vision at multiple distances. The study measures changes in visual acuity, satisfaction, and any side effects.

What this could mean

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

Active substance
an iris-fixated multifocal intraocular lens called Artiflex Presbyopic (Artiplus)
What this could lead to
If it works, this lens could offer a surgical option for people with presbyopia who want to reduce their dependence on reading glasses.
What could go wrong
This is a small, early trial with 49 participants. The lens may not provide the hoped-for vision improvement, and risks include infection, inflammation, or the need for further surgery.

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

About 49 people

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

Started

Nov 2021

Expected to finish

Nov 2026

An estimate. End dates often move.

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

18 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: * Presbyopic adult * Potential for binocular vision * Subject wishes to be spectacle independent for near and far vision * Refractive error that can be corrected with correction at PIOL plane from +2.0 to -15.0 D * Subject requiring a presbyopic correction Patients with reading glasses of minimum +1D. * Stable refraction (±0.75 D), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum of 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history * Expected best corrected visual acuity of 0.2 logMAR (0.63 Snellen decimal) or better after lens implantation * Current contact lens wearer should demonstrate a stable refraction (± 0.5 D), expressed as subjective refraction spherical equivalent, on two consecutive examination dates performed at least 7 days apart. Before the first refraction, the contact lens wearer should not have worn lenses for at least 2 weeks in case of rigid and toric contact lenses, or 3 days for spherical soft contact lenses. * Any subject, who is expected to have a residual postoperative cylindrical refractive error of below 0.75 D * Ability to give informed consent * Availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study Exclusion Criteria: Pre-existing pathology or physiology which may be aggravated by the implant or where the implant may interfere with the possibility of examining or treating disease: * Preoperative ocular or systemic condition or medication use that would be expected to present undue risk to the subject, that can predispose for future complications or confound the outcome(s) of the study. E.g. the systemic use of alpha-1a adrenergic receptor antagonists was suggested to increase the occurrence of intraoperative floppy iris syndrome, alter iris morphology - or more specifically reduce iris thickness at the site of potential IOL enclavation - and increase postoperative endothelial cell loss. * Previous ocular surgery which might affect the outcome of the study * Concurrent participation or participation during the last 30 days in another drug or device investigation * Secondary surgical procedure planned during the first 6 months of the study (e.g. laser treatment to correct astigmatism) * Amblyopia * Preoperative anterior chamber depth measurement of below 3.0 mm for subjects \< 40 years old and 2.8 mm for subjects \> 40 years old. Anterior chamber depth is being measured from corneal endothelium to the anterior pole of the crystalline lens. This will result in a critical distance between PIOL and endothelium of 1.5 mm or more as simulated with anterior segment imaging. * White-to-white smaller than 10.5 mm * Subjects not meeting the age specific minimum preoperative endothelial cell density as defined below: 31 to 35 years of age 2400 cells/mm2; 36 to 45 years of age 2200 cells/mm2; \> 45 years of age 2000 cells/mm2 * Corneas with high rates of polymegethism (a coefficient of variation over 0.40) and pleomorphism (the presence of less than 50% hexagonal cells). * Abnormal iris (e.g. convex, bulging or volcano shaped iris) * Crystalline lens rise of 600 µm or more * Abnormal cornea (keratoconus, opaque cornea, corneal scars, post corneal transplant, corneal dystrophy, or other) * Ocular surface conditions which might influence the quality of vision and affect the outcome of the study * Abnormal pupil (e.g. nonreactive, fixed) * Ectopic pupil * Pupil in photopic light conditions smaller than 2.6 mm * Pupil in scotopic light conditions greater than 7.0 mm * High preoperative intraocular pressure (\>21 mm Hg) * Cataract of any grade * Glaucoma or family history of glaucoma (dependent on the evaluation of physician) * Diabetes or diabetic retinopathy * Acute or chronic inflammation * Chronic or recurrent uveitis or family history of the same condition * Retinal detachments or family history of retinal detachments * Corticosteroid responder * Pregnant or nursing * Unstable refraction (≥ 0.5D of variability in refraction over the last 12 months) * Aged under 18

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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

  • CIMO

    Seville, Seville, Spain

  • GM st. Mary's Eye clinic

    Busan, Busan, South Korea

  • Hospital San Rafael

    Madrid, Madrid, Spain

  • ICQO

    Bilbao, Biscay, Spain

  • IMO

    Barcelona, Catalonia, Spain

  • Nune Eye Hospital Daegu

    Seoul, Seoul, South Korea

  • SU Yonsei Eye Clinic

    Seoul, Seoul, South Korea

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