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

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.

Conditions

• Cataract and IOL Surgery
• IOL Implantation
• Presbyopia Correction
• Extended Depth of Focus

Interventions

DEVICE

Bilateral implantation of CT ASPHINA 409M

Patients will be implanted with CT ASPHINA 409M during catarct surgery. The CT Asphina 409M has been commercially available for several years and is widely used in clinical practice. Designed with aberration-neutral optical properties, it could improve contrast sensitivity and visual quality. This monofocal aspheric IOL features four-point plate haptics and a one-piece design made from hydrophilic acrylic material with hydrophobic surface properties. It also has an overall diameter of 11 mm and a 6 mm optical diameter. The lens has a sharp posterior optic edge to minimize posterior capsule opacification. It is ideally suited as a comparative referent lens to new EDOF IOLs.

DEVICE

Bilateral implantation of TECNIS Eyhance ICB00

Patients will be implanted with TECNIS Eyhance ICB00 during catarct surgery. TECNIS Eyhance ICB00 is a one-piece, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The lens has a spherical posterior surface and a modified aspheric anterior surface that offers a smooth and continuous change in power from the periphery to the center of the lens, without a demarcation zone.

DEVICE

Bilateral implantation of AcrySof® IQ Vivity®

Patients will be implanted with AcrySof® IQ Vivity® during catarct surgery. The AcrySof® IQ Vivity® is a single-piece, hydrophobic acrylic IOL that utilizes non-diffractive wavefront-shaping technology (X-wave™) on its anterior surface to achieve an extended range of vision. Its aspheric anterior surface features a 2.2 mm central zone composed of two smooth transition elements: the first forms a slightly elevated plateau (\~1 µm) that stretches the wavefront, while the second shifts the wavefront to create a negative extended focal range. Together, these elements could create advanced and delayed wavefronts resulting in a continuous extended focal range instead of multiple focal points, while optimizing light transmission. This UV-absorbing and blue light filtering foldable IOL has a refractive index of 1.55 at 35 °C, an optic diameter of 6 mm and an overall length of 13 mm. The lens is available in spherical powers ranging from +10.0 to +30.0 diopters.

DEVICE

Bilateral implantation of LuxSmart™

Patients will be implanted with LuxSmart™ during catarct surgery. The LuxSmart™ intraocular lens is a single-piece, acrylic hydrophobic and aspheric IOL with an overall diameter of 11 mm, an optical diameter of 6 mm, and a 4-point fixation haptic design. This non-diffractive IOL utilizes a technology known as Pure Refractive Optics (PRO), incorporating a 2.0 mm central EDOF zone that combines fourth- and sixth-order spherical aberrations of opposite signs designed to improve perceived depth of focus. The paracentral region, on the other hand, is a transition zone meant to gradually decrease the optic vergence from the center to the monofocal periphery. It has also a 360° continuous square edge on the posterior surface to prevent epithelial lens cells migration and posterior capsule opacification.

DEVICE

Bilateral implantation of Eyecryl SERT

Patients will be implanted with Eyecryl SERT during catarct surgery. EyeCryl-SERT (Biotech) is a new advanced monofocal, single-piece hydrophobic IOL with an aspheric surface, continuous vision from distance to intermediate, spectacle independence for intermediate vision, an extended range of vision: \>1.75 D at spectacle plane with visual acuity 0.2 LogMAR or better, an intermediate vision up to 57 cm and a design for fast neural adaptation.

DEVICE

Bilateral implantation of RayOne EMV

Patients will be implanted with RayOne EMV during catarct surgery. RayOne EMV (Rayner) is a new EDOF lens that has recently emerged in the market. It is a truly non-diffractive, single-piece hydrophilic IOL which does not use light splitting technology like many IOLs which increase depth of focus, resulting in low levels of dysphotopsia, similar to standard monofocal lenses. RayOne EMV is the only patented aspheric IOL that induces controlled positive spherical aberration. Compared to a lens with zero spherical aberration, the carefully controlled positive spherical aberration induced by RayOne EMV spreads light along the visual axis, elongating the focal range from far into intermediate with up to 1.5 D of depth of focus (per lens on the spectacle plane).

Sponsors & Collaborators

• Augenklinik Ahaus G + H GmbH & Co. KG

  lead OTHER

Principal Investigators

• Labib Alshaweesh, MD, MSc · Augenklinik Ahaus

• Matthias Müller, Dipl.-Ing.FH · Augenklinik Ahaus

• dr. med. (Univ. Bud.) Matthias Gerl, MD · Augenklinik Ahaus

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

22 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-12

Primary Completion

2025-10-31

Completion

2026-01-31

FDA Device

Yes

Countries

• Germany

Study Locations