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Cataract lens breakthrough? new implant could let you ditch glasses

NCT ID NCT07092020

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Updated 2 times

Summary

This study tests a new type of lens implant (extended depth of focus IOL) for people with age-related cataracts. The lens is designed to provide clear vision at multiple distances, potentially reducing the need for glasses after surgery. About 220 adults will be randomly assigned to receive either the new lens or a standard monofocal lens, and their vision will be compared over time.

What this could mean

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

Active substance
extended depth of focus intraocular lens (IOL)
What this could lead to
If it works, this lens could help people see clearly at near, intermediate, and far distances after cataract surgery, reducing dependence on glasses.
What could go wrong
This is a relatively small trial (220 people) comparing a new lens to a standard one. The new lens may not provide better vision or could cause more visual disturbances like glare.

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

220 people

The number who actually took part.

Started

Oct 2025

Finished

Jul 2026

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

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. Patients of any gender, aged 18 years or older 2. Patient with clinically significant bilateral age-related cataracts planned for phacoemulsification cataract extraction and eligible for implantation of a posterior chamber intraocular lens as determined by investigator's medical judgement 3. Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D) 4. Calculated lens power within the available range 5. Clear intraocular media other than cataract 6. Patient is willing and capable of providing informed consent 7. Patient is willing and capable of complying with visits and procedures as defined by this protocol Exclusion Criteria: 1. Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal) 2. Endothelial cell count of less than 2000/mm2 3. Acute, chronic, or uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to poorly controlled diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc. 4. Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry eye, anterior segment pathology, uncontrolled glaucoma, that would result in a visual acuity of 0.2 logMAR or worse during the study 5. Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity or oedema as per Investigator's medical judgement; conditions including but not limited to kerato-uveitis, keratopathy, keratectasia 6. Previous intraocular or corneal/refractive surgery that might confound the outcome of the investigation or increase the risk to the patient (including corneal transplants, removal of pterygium, and LASIK, LASEK, PRK, RK limbal relaxing incision etc.) 7. Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.) 8. Patients with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders, optic nerve atrophy etc.) or any other pathologies of the eye that are predicted to result in a visual acuity of 0.2 logMAR or worse during the study 9. Current systemic or ocular pharmacotherapy that effects patients' vision with significant ocular side effects or any medications that could confound the outcome or increase subject risk 10. Clinically significant gonioscopic abnormalities 11. Amblyopia, strabismus, single eye status 12. Rubella, congenital, traumatic or complicated cataracts 13. History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis 14. Microphthalmos or macrophthalmos 15. Pupil abnormalities (e.g. aniridia, abnormal shaped pupils, nonreactive pupils) 16. Pseudoexfoliation 17. Keratoconus or irregular astigmatism 18. Inability to measure keratometry or biometry (including but not limited to cataract density, etc.) 19. Pathologic miosis 20. Pregnant, plan to become pregnant, lactating during the course of the investigation, or another condition with associated fluctuation of hormones that could lead to refractive changes 21. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial 22. Patients whose freedom is impaired by administrative or legal order 23. Concurrent participation in another clinical investigation in the last 30 days.

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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

  • Eye Hospital Zora

    Sofia, Bulgaria

  • Hospital Universitario Ramón y Cajal

    Madrid, Spain

  • Medical Center "Vereya"

    Stara Zagora, Bulgaria

  • Medoptic Clinic

    Suceava, Romania

  • Nemocnice Havlíčkův

    Havlíčkův Brod, Czechia

  • OFTEX ocni

    Pardubice, Czechia

  • OMIQ Hospital Universitari

    Sant Cugat del Vallès, Spain

  • Oculus Eye Clinic

    Bucharest, Romania

  • Ofta Total Clinic

    Sibiu, Romania

  • Oftalvist

    Alicante, Spain

  • Oftalvist

    Valencia, Spain

  • Oční Centrum

    Prague, Czechia

  • Specialized Ophthalmological Hospital for Active Treatment

    Sofia, Bulgaria

  • University Hopital Complex of Santiago de Compostela

    Santiago de Compostela, Spain

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