New lens offers hope for better vision after cataract surgery
NCT ID NCT04249492
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new type of lens (EDOF) for people having cataract surgery, comparing it to a standard lens. The goal was to see if the new lens could improve vision at different distances while being safe. 250 adults aged 45 and older with cataracts took part, and the results showed no major difference in distance vision between the two lenses.
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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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250 people
The number who actually took part.
- Started
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Feb 2020
- Finished
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Apr 2024
- 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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45 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * Cataractous eyes with no comorbidity; * Calculated IOL power is within the range of the study IOLs; * Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes; * Regular corneal astigmatism ≤1.0 D (measured by an automatic keratometer) * Clear intraocular media other than cataract; * Availability, willingness and sufficient cognitive awareness to comply with examination procedures; * Signed informed consent. Exclusion Criteria: * Age of patient \< 45 years; * Regular corneal astigmatism \>1.0 dioptres (measured by an automatic keratometer) * Irregular astigmatism; * Difficulty for cooperation (distance from their home, general health conditions); * Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse; * Subjects with AMD suspicious eyes as determined by OCT examination; * Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema; * Previous intraocular or corneal surgery; * Traumatic cataract; * History or presence of macular edema; * Instability of keratometry or biometry measurements; * Ocular hypertension or glaucoma; * Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions); * Expected complicated surgery; * Significant dry eye.
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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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Asian Eye Institute
Makati City, 1200, Philippines
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Augen-Zentrum-Nordwest
Ahaus, 48683, Germany
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Augentagesklinik Rheine
Rheine, 48429, Germany
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Gemini Eye Clinic
Zlín, 76001, Czechia
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Hanusch Krankenhaus
Vienna, 1140, Austria
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Hospital Clínico San Carlos
Madrid, 28040, Spain
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Institute of Eye Surgery
Waterford, X91 DH9W, Ireland
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Institute of Eye Surgery - Clane
Kildare, W91 W535, Ireland
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Miranza IOA Madrid
Madrid, 28003, Spain
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Oftalvist Alicante
Alicante, 03016, Spain
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Smile Eyes Augen + Laserzentrum
Leipzig, 04107, Germany
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Universitäts-Augenklinik Heidelberg
Heidelberg, 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?