Cataract lens breakthrough? new implant could let you ditch glasses
NCT ID NCT07092020
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
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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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220 people
The number who actually took part.
- Started
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Oct 2025
- Finished
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Jul 2026
- 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: 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
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Eye Hospital Zora
Sofia, Bulgaria
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Hospital Universitario Ramón y Cajal
Madrid, Spain
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Medical Center "Vereya"
Stara Zagora, Bulgaria
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Medoptic Clinic
Suceava, Romania
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Nemocnice Havlíčkův
Havlíčkův Brod, Czechia
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OFTEX ocni
Pardubice, Czechia
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OMIQ Hospital Universitari
Sant Cugat del Vallès, Spain
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Oculus Eye Clinic
Bucharest, Romania
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Ofta Total Clinic
Sibiu, Romania
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Oftalvist
Alicante, Spain
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Oftalvist
Valencia, Spain
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Oční Centrum
Prague, Czechia
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Specialized Ophthalmological Hospital for Active Treatment
Sofia, Bulgaria
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University Hopital Complex of Santiago de Compostela
Santiago de Compostela, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can laser precision improve astigmatism correction during cataract surgery?
- Micro-Coil stent aims to drain glaucoma pressure during cataract surgery
- Could your phone replace a Post-Surgery eye check?
- Warm compress device shows promise for dry eyes before cataract surgery
- New lens aims to sharpen vision after cataract surgery
- Cataract lens still clear after 2 years? study checks for glistening