CompletedNot Applicable

Visual Performance of Patients Implanted With a Multifocal IOL

Germany, Spain69 participantsStarted 2023-10-31

Plain-language summary

The goal of this clinical trial is to learn about the visual performance of a new multifocal intra-ocular lens in patients presenting for cataract or refractive lens exchange surgery. The main question it aims to answer is: What is the visual performance and patient satisfaction twelve months post-operatively? Participants will receive bilateral implantation of the investigational device, undergo post-operative assessments, and provide feedback on their overall visual satisfaction.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 z…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean monocular best-corrected distance visual acuity (CDVA)

Timeframe: Three (3) Months

Trial details

NCT IDNCT06111222

SponsorCarl Zeiss Meditec AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-13

View on ClinicalTrials.gov More Cataract trials