Actively Recruiting
Head-to-Head Comparison of Five Enhanced Depth of Focus IOLs and One Monofocal IOL
Led by Augenklinik Ahaus G + H GmbH & Co. KG · Updated on 2025-07-04
180
Participants Needed
1
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Head-to-Head Comparison of Five Enhanced Depth of Focus IOLs and One Monofocal IOL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Endothelial cell density less than 2,000 cells/mm�b2
- Required IOL power for emmetropia outside the +10.0 D to +30.0 D range
- Pupillary abnormalities
- Intraocular inflammation
- Recent unresolved or unstable ocular trauma or surgery
- History of corneal refractive surgery such as LASIK, LASEK, or PRK
- Irregular astigmatism or corneal abnormalities/opacities
- Conditions increasing risk of zonular rupture causing IOL decentration or tilt
- Systemic or ocular diseases or medications impairing vision or increasing surgical risk
- Clinically significant dry eye disease affecting vision
- Need for retinal laser treatment or other ocular surgery during study
- Pregnancy, planned pregnancy, breastfeeding, or hormonal conditions causing refractive changes
- Continuous contact lens wear within the past 4 weeks
- Inability to understand or complete study questionnaires
- Advanced glaucoma with visual field defects
- Age-related macular degeneration (exudative or geographic)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Augenklinik Ahaus
Ahaus, North Rhine-Westphalia, Germany, 48683
Actively Recruiting
Research Team
D
dr. med. (Univ. Bud.) Matthias Gerl, MD
CONTACT
M
Matthias Müller, Dipl.-Ing.FH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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