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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-85
SponsorAugenklinik Ahaus G + H GmbH & Co. KG

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Bilateral implantation of CT ASPHINA 409M
  • Bilateral implantation of TECNIS Eyhance ICB00
  • Bilateral implantation of AcrySof® IQ Vivity®
  • Bilateral implantation of LuxSmart™
  • Bilateral implantation of Eyecryl SERT
  • Bilateral implantation of RayOne EMV

Treatment groups

180 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.