New cataract lens aims for sharper sight
NCT ID NCT07471295
First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times
Summary
This study tests a special lens used during cataract surgery to see how well it improves vision. About 130 adults with cataracts will get the lens and have their eyesight checked afterward. The goal is to make sure the lens is safe and helps people see more clearly.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Feb 2028
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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18 years and older
- 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: * Aged 18 years or older; * Patients willing, able, and with sufficient cognitive awareness to comply with examination procedures and schedule for follow-up visits; * Patients with clinically significant age-related cataract (cataract grades of 1, 2, 3 on the LOCSIII scale, but otherwise healthy, requiring surgical treatment, and scheduled for unilateral or bilateral phacoemulsification or Femtosecond-Laser-Assisted cataract surgery; * Patients with existing regular corneal astigmatism of minimum 0.75 D in at least the first eye to be operated. * Signed informed consent form; * Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment; * Calculated IOL power within the range of the investigational IOL; SE +18.0 D to +28.0 D (0.5 D Steps), and between a Cylinder range of +1.0 D to +2.5 D (0.5 D Steps); * Dilated pupil size large enough to visualize TIOL axis markings postoperatively; at least 5.5mm; * Clear intraocular media other than cataract. Exclusion Criteria: * Previous intraocular or corneal surgery in either eye that might confound the outcome of the study or increase the risk to the subject; * Keratometric astigmatism (assessed by IOL Master) of minimum 0.75 D in the first eye * Traumatic cataract; * Pregnancy or lactation; * Concurrent participation in another drug or device investigation within the last 30 days; * Irregular astigmatism; * Instability of keratometry or biometry measurements; * Subjects wearing contact lenses as standard vision aid; * Abnormal pupil; * Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.); * History of concurrent intraocular inflammation; * Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or clinically significant corneal membrane dystrophies); * History of any clinically significant retinal or ocular pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis; * Pseudoexfoliation syndrome (according to investigator judgement); * Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment; * All kind of infections (acute ocular disease, external / internal infection, systemic infection); * Monophthalmic patient; * Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus, Parkinson disease * Patient expected to require retinal laser treatment before the end of the last follow-up examination; * Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination; * Patients who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than Nd:YAG capsulotomy) * In case of both eyes included in this trial: Patients who need to undergo surgery on both eyes on the same day
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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
6 sites in 4 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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Ayrshire Eye Clinic
NOT_YET_RECRUITINGAyr, Ayrshire, KA7 2SP, United Kingdom
Contact Email: •••••@•••••
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Ofatlivist Alicante
RECRUITINGAlicante, 03001, Spain
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Oční Centrum Praha
RECRUITINGPrague, Czechia
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Oční klinikaO
RECRUITINGPrague, Prague, 18100, Czechia
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PVK Precise Vision GmbH
NOT_YET_RECRUITINGRheine, 48429, Germany
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Universitätsklinikum Heidelberg
NOT_YET_RECRUITINGHeidelberg, 69120, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A lens that could let cataract patients see near and far without glasses
- One operation for cataract and glaucoma? eye surgeons test a Two-in-One approach
- Eye drops may shield the cornea after cataract surgery
- A simple blood draw might reveal hidden eye lymphoma
- Can a new lens make glasses obsolete after cataract surgery?
- Can a new lens design sharpen vision after macular surgery?