RecruitingNot Applicable

Head-to-Head Comparison of Five Enhanced Depth of Focus IOLs and One Monofocal IOL

Germany180 participantsStarted 2022-04-12

Plain-language summary

Study Goal The goal of this clinical trial is to compare how well four different types of artificial lenses (called intraocular lenses or IOLs) help people see after cataract surgery. The main questions it aims to answer are: Which lens gives the best vision at different distances (far, middle, and close)? How satisfied are patients with their vision after surgery? How often do patients still need glasses after surgery? Who Can Participate Adults aged 22 to 85 years who need cataract surgery in both eyes and meet specific health requirements. Study Design Researchers compared six different lens types: TECNIS Eyhance - designed to improve middle-distance vision AcrySof IQ Vivity - extends the range of clear vision LuxSmart - uses special optics for better depth of focus Rayner EMV - uses gradual light-bending technology for smooth vision transition Eycryl SERT - modifies light focus to extend clear vision range CT ASPHINA 409M - standard single-focus lens (comparison group) Participants chose their preferred lens type after learning about each option's benefits and limitations. What Participants Do? Participants will: Have cataract surgery on both eyes (1-2 weeks apart) Complete vision tests at multiple distances Take contrast sensitivity tests under different lighting conditions Fill out questionnaires about vision quality and daily activities Attend follow-up visits at 1 day, 1 week, 1 month, and 3 months This study helps patients and doctors make informed decisions about which type of artificial lens might work best for individual needs and lifestyle.

Who can participate

Age range

22 Years – 85 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: * Bilateral implantation of the same intraocular lens (IOL) model * Expected postoperative best-corrected distance visual acuity (BCDVA) of 0.8 (decimal) or better * Regular corneal astigmatism less than 1 diopter Exclusion Criteria: * Endothelial cell density \< 2,000 cells/mm² * Required IOL power for emmetropia falls outside the available range of +10.0 D to +30.0 D * Pupillary abnormalities * Intraocular inflammation * Recent ocular trauma or ocular surgery that is unresolved/unstable, or which may impair visual outcomes or increase patient risk * History of corneal refractive surgery (e.g., LASIK, LASEK, PRK) * Irregular astigmatism, as well as corneal abnormalities or opacities * Conditions associated with an increased risk of zonular rupture, including capsular or zonular anomalies that may lead to IOL decentration or tilt, such as pseudoexfoliation syndrome, trauma, Marfan syndrome, among others * Systemic or ocular diseases, or medications, that may impair vision, increase surgical risk, or confound study outcomes * Clinically significant dry eye disease affecting visual function * Anticipated need for retinal laser treatment or any other ocular surgical intervention during the study period * Pregnancy, planned pregnancy, breastfeeding, or any condition associated with hormonal fluctuations that may induce refractive changes * Continuous contact lens wear within the past 4 weeks * Inability to understand and/or complete study questionnaires * A…

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.