Actively Recruiting

Phase Not Applicable
Age: 22Years - 85Years
All Genders
NCT07051720

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

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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

Age: 22Years - 85Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Augenklinik Ahaus

Ahaus, North Rhine-Westphalia, Germany, 48683

Actively Recruiting

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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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