Can a new lens give sharper sight at all distances?
NCT ID NCT06111222
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This trial investigates how well a new multifocal intraocular lens, the AT ELANA, improves vision in people having cataract or refractive lens exchange surgery. About 69 participants will receive the lens in both eyes and be followed for 12 months to measure visual sharpness and satisfaction. The goal is to see if the lens provides clear vision at near, intermediate, and far distances, potentially reducing dependence on glasses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a multifocal intraocular lens called AT ELANA
- What this could lead to
- If successful, this lens could provide clearer vision at multiple distances, reducing the need for glasses after cataract or lens exchange surgery.
- What could go wrong
- This is a small, non-randomized study with no control group, so results may not apply broadly. Some patients may experience glare or halos with multifocal lenses.
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
-
69 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Jan 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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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: * Age 18 years or older; * Patients scheduled for bilateral AT ELANA 841P phacoemulsification cataract extraction or Femtosecond-Laser-Assisted-Cataract-Surgery (cataract grades of 1, 2, 3 on the LOCSIII scale) and IOL implantation (Cataract or PRELEX) with a maximum of 28 days between both implantations; Calculated IOL power within the limited IOL Diopter range of +15.0D to +27.0D * No visual acuity limiting pathologies other than cataract; * Corneal Astigmatism of \<1.0 D; * Availability, willingness, and sufficient cognitive awareness to comply with examination procedures; * Written informed consent for participation in the study and data protection. Exclusion Criteria: * Corneal Astigmatism of ≥1.0 D; * Difficulty for cooperation (distance from their home, general health conditions); * History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, OHT, glaucoma suspect, glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.); * Visual field loss which has an impact on visual acuity; * Use of systemic or ocular medication that might affect vision; * Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus; * Pupil abnormalities (non-reactive, tonic pupils, abnormal myosis or mydriasis, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions); * Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g., pseudoexfoliation syndrome); * Cataract grades of 4, 5 or 6 on the LOCSIII scale ; * Surgeries with incision size of ≥2.75mm ; * Immediate Sequential Bilateral Cataract Surgery ; * Concurrent participation in another device investigation; * Usage of contact lenses during participation.
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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
-
Ofatlivist Alicante
Alicante, 03001, Spain
-
PVK Precise Vision GmbH
Rheine, 48429, Germany
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Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
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