A lens that could let cataract patients see near and far without glasses

NCT ID NCT05955846

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Cataracts cloud the eye's lens and blur vision, and presbyopia makes it hard to focus up close after age 50. Researchers are testing an intraocular lens with a virtual aperture optic, implanted during cataract surgery, to see if it improves vision at distance, intermediate, and near. The trial enrolls 60 adults aged 40 to 75 who have cataracts in both eyes. Each participant receives the lens in both eyes, one month apart, and researchers track their vision for 12 months.

What this could mean

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

Active substance
an intraocular lens with a virtual aperture optic (device IOL FG-80030.1)
What this could lead to
If it works, people who have cataract surgery could see clearly at distance and near without glasses, easing the reading and computer-vision problems that come with presbyopia.
What could go wrong
The trial is small, with 60 participants, and early. The lens may not improve near vision enough, and any eye surgery carries risks such as infection, swelling, or glare that could limit how well it works for everyday tasks.

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 60 people

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

Started

Aug 2025

Expected to finish

Sep 2027

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

40 to 75 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: 1. Adults, Age 40 to 75 years at the time of surgery, diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision and posterior chamber IOL implantation; 2. Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/30 Snellen; 3. Clear intraocular media, other than cataract; 4. Calculated lens power within the available range (available range of +16 D to +24 D); 5. Preoperative keratometric astigmatism of less than 0.75 D in both operative eyes; 6. Potential for postoperative BCDVA of 20/25 or better in each eye after cataract removal and IOL implantation; 7. Able to comprehend and have signed a statement of informed consent; 8. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits; Exclusion Criteria: 1. Desire for monovision correction 2. History of Dry Eye treatments/devices (example IPL, Lipiflow, iLux, Tear Care, Bruder Mask, True Tear) or any dry eye medications other than artificial tears (example, Restasis, Xiidra, Cequa, Klarity-C, generic cyclosporine/compounded cyclosporine) 3. Active or recurrent anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, Reiter's syndrome, etc.); 4. Clinically significant corneal abnormalities or defects including corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy), irregularity (including irregularity due to dry eye syndrome), inflammation or edema per the Investigator's expert medical opinion. Note: conditions including, but not limited to: keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or keratectasia should be excluded; 5. Previous corneal or intraocular surgery; 6. Irregular corneal astigmatism; or regular corneal astigmatism greater than or equal to +/-0.75D; 7. Inability to achieve stable keratometric readings for contact lens wearers; \*The recommended time for discontinued wear of extended-wear or daily wear soft lenses is one week prior to surgery, one month for gas permeable and six months for PMMA lenses. No evidence of significant corneal warpage from contact lens use should be present on corneal topography and if the subject has been wearing a rigid gas permeable contact lens there should be two stable serial topographies at least 1 month following cessation of contact lens wear 8. Higher-order Zernike corneal aberrations (3rd -order and above) RMS value greater than 1.0 um for the central 6-mm diameter area; 9. Pupil dilation in scotopic conditions \>5mm 10. Use of systemic or ocular medications that may affect vision or likely to impact pupil dilation or iris structure; 11. Pharmacologically dilated pupil size less than 6 mm in either eye; 12. Pupil abnormalities; 13. History of ocular trauma, prior refractive or other ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention; 14. Any disease or pathology, other than cataract, that (in the expert opinion of the Investigator) is expected to reduce the potential postoperative BCDVA. Note: Conditions including, but not limited to the following: amblyopia, clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy), diabetic retinopathy, extremely shallow anterior chamber, not due to swollen cataract, microphthalmos, previous retinal detachment, previous corneal transplant, recurrent severe anterior or posterior segment inflammation of unknown etiology, iris; neovascularization, uncontrolled glaucoma, aniridia, or optic nerve atrophy, or diagnosis of pseudoexfoliation; 15. Neovascularization, uncontrolled glaucoma, aniridia, or optic nerve atrophy; 16. Subjects who have profound sensitivity to glare at night with oncoming traffic headlights or subjects who are sensitive to fluorescent light flicker; 17. Subjects who may reasonably be expected to require a SSI at any time during the study (other than YAG capsulotomy); 18. Subject is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye. Females of childbearing age must have a negative pregnancy test at screening in order to be enrolled into the study. 19. Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit; 20. Acute, chronic, or uncontrolled systemic or ocular disease or any illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., poorly-controlled diabetes);

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites in 3 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Augenclinic Mallorca

    RECRUITING

    Palma de Mallorca, Spain

    Contact Email: •••••@•••••

  • Ceuta Medical Center

    RECRUITING

    Ceuta, Spain

    Contact Email: •••••@•••••

  • Hospital Arruzafa

    RECRUITING

    Córdoba, Spain

    Contact Email: •••••@•••••

  • Oftalvist Alicante

    RECRUITING

    Alicante, Spain

  • Oftalvist Madrid

    RECRUITING

    Madrid, Spain

  • Orasis

    RECRUITING

    Reinach, Switzerland

  • Portugal Site 2

    RECRUITING

    Coimbra, Portugal

  • Portugal Site 3

    NOT_YET_RECRUITING

    Lisbon, Portugal

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