A lens that could let cataract patients see near and far without glasses
NCT ID NCT05955846
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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40 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
8 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Locations
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Augenclinic Mallorca
RECRUITINGPalma de Mallorca, Spain
Contact Email: •••••@•••••
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Ceuta Medical Center
RECRUITINGCeuta, Spain
Contact Email: •••••@•••••
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Hospital Arruzafa
RECRUITINGCórdoba, Spain
Contact Email: •••••@•••••
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Oftalvist Alicante
RECRUITINGAlicante, Spain
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Oftalvist Madrid
RECRUITINGMadrid, Spain
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Orasis
RECRUITINGReinach, Switzerland
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Portugal Site 2
RECRUITINGCoimbra, Portugal
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Portugal Site 3
NOT_YET_RECRUITINGLisbon, Portugal
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- Can a new lens make glasses obsolete after cataract surgery?