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

Recruiting now · Not applicable

Conditions studied: Cataract and IOL Surgery, IOL Implantation, Presbyopia Correction, Extended Depth of Focus

In brief

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.

Key facts

Study ID: NCT07051720
Run by: Augenklinik Ahaus G + H GmbH & Co. KG
People needed: 180
Starts: 2022-04-12
Expected to finish: 2026-01-01
Last updated by the study team: 2025-07-04

Who can join

Age: 22 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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
Advanced glaucoma with visual field defects
Age-related macular degeneration (exudative or geographic form)

Where it is running

Augenklinik Ahaus — Ahaus, North Rhine-Westphalia, Germany (enrolling)

Full record on ClinicalTrials.gov

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