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

NCT07051720 | Recruiting FDA Device

• 1 other identifier: 2020-819-f-S
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cataract surgery; Extended depth-of-focus; EDOF; Intraocular lens; Presbyopia correction; Spectacle independence; Visual outcomes; Patient satisfaction; TECNIS Eyhance; AcrySof IQ Vivity; LuxSmart; CT Asphina; RayOne EMV; Eyecryl SERT

Outcome Measures

Primary Outcomes (7)

• Distance-Corrected Intermediate Visual Acuity at 80cm (Unit: LogMAR)

  Monocular and binocular measurements of distance-corrected intermediate visual acuity (DCIVA) at 80cm in LogMAR.

  From enrollment to the end of 3-month follow-up

• Distance-Corrected Intermediate Visual Acuity at 60cm (Unit: LogMAR)

  Monocular and binocular measurements of distance-corrected intermediate visual acuity (DCIVA) at 60cm in LogMAR.

  From enrollment to the end of 3-month follow-up

• Binocular Defocus Curve (Unit: LogMAR)

  Following subjective refraction and determination of BCDVA, binocular defocus curve testing will be performed to evaluate the visual performance by adding defocus lenses from + 1.50 D to - 2.50 D in a randomized order.

  From enrollment to the end of 3-month follow-up

• BInocular depth of Focus at 0.1 LogMAR threshold (Unit: Diopters)

  In order to comply with the recommendations of the American National Standards Institute (ANSI) Z80.35-2018 guideline regarding the definition of the EDOF IOLs, the binocular depth of focus will be calculated from the binocular defocus curve at 0.1 LogMAR threshold.

  From enrollment to the end of 3-month follow-up

• Binocular Contrast Sensitivity Function (Unit: Log units)

  Using the Functional Vision Analyzer (Optec 6500, Stereo Optical Co., Chicago, IL, USA) across five spatial frequencies (1.5, 3.0, 6.0, 12.0, and 18.0 cycles per degree) under three standardized lighting conditions (photopic, mesopic, mesopic with glare).

  From enrollment to the end of the 3-month follow-up

• Vision-related quality of life (Unit: Points on 0-100 scale)

  Using the validated Visual Function Index-14 (VF-14) questionnaire.

  From enrollment to the end of 3-month follow-up

• Visual symptoms and their impact on daily life (Unit: QoV score 0-100)

  Using the validated McAlinden's Quality of Vision questionnaire.

  From enrollment to the end of 3-month follow-up

Secondary Outcomes (5)

• Corrected distance visual acuity in LogMAR

  From enrollment to the end of 3-month follow-up

• Distance-corrected near visual acuity in LogMAR

  From enrollment to the end of 3-month follow-up

• Endothelial cell density, cells/mm²

  From enrollment to the end of 3-month follow-up

• Safety outcomes

  From enrollment to the end of 3-month follow-up

• The development of posterior capsule opacification (PCO) on a scale

  From enrollment to the end of 3-month follow-up

Study Arms (6)

CT ASPHINA 409M IOL group

EXPERIMENTAL

The monofocal intraocular lens CT ASPHINA 409M (Carl Zeiss Meditec AG, Germany) will be implanted during catarct surgery

Device: Bilateral implantation of CT ASPHINA 409M

TECNIS Eyhance ICB00 IOL group

EXPERIMENTAL

The intraocular lens TECNIS Eyhance ICB00 (Johnson \& Johnson Surgical Vision, Irvine, CA, USA) will be implanted during catarct surgery

Device: Bilateral implantation of TECNIS Eyhance ICB00

AcrySof® IQ Vivity® IOL group

EXPERIMENTAL

The intraocular lens AcrySof® IQ Vivity® (Alcon Laboratories, Fort Worth, TX, USA) will be implanted during catarct surgery

Device: Bilateral implantation of AcrySof® IQ Vivity®

LuxSmart™ IOL group

EXPERIMENTAL

The intraocular lens LuxSmart™ (Bausch+Lomb, Rochester, NY, USA) will be implanted during catarct surgery

Device: Bilateral implantation of LuxSmart™

Eyecryl SERT IOL group

EXPERIMENTAL

The intraocular lens Eyecryl SERT (Biotech Healthcare Group, Luzern, Switzerland) will be implanted during catarct surgery

Device: Bilateral implantation of Eyecryl SERT

RayOne EMV IOL group

EXPERIMENTAL

The intraocular lens RayOne EMV (Rayner Intraocular Lenses Ltd.) will be implanted during catarct surgery

Device: Bilateral implantation of RayOne EMV

Interventions

Bilateral implantation of CT ASPHINA 409M DEVICE

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.

CT ASPHINA 409M IOL group

Bilateral implantation of TECNIS Eyhance ICB00 DEVICE

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.

TECNIS Eyhance ICB00 IOL group

Bilateral implantation of AcrySof® IQ Vivity® DEVICE

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.

AcrySof® IQ Vivity® IOL group

Bilateral implantation of LuxSmart™ DEVICE

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.

LuxSmart™ IOL group

Bilateral implantation of Eyecryl SERT DEVICE

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.

Eyecryl SERT IOL group

Bilateral implantation of RayOne EMV DEVICE

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).

RayOne EMV IOL group

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Augenklinik Ahaus G + H GmbH & Co. KG: lead

Study Sites (1)

Augenklinik Ahaus

Ahaus, North Rhine-Westphalia, 48683, Germany

RECRUITING

MeSH Terms

Conditions

Cataract; Patient Satisfaction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Labib Alshaweesh, MD, MSc

  Augenklinik Ahaus

  STUDY DIRECTOR

• Matthias Müller, Dipl.-Ing.FH

  Augenklinik Ahaus

  STUDY DIRECTOR

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

  Augenklinik Ahaus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

dr. med. (Univ. Bud.) Matthias Gerl, MD

CONTACT

+49 (2561) 9555-301; m.gerl@augenklinik.de

Matthias Müller, Dipl.-Ing.FH

CONTACT

+49 (0)2561-9555-247; M.Mueller@augenklinik.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO

Model Details: This was a prospective, single-center, patient-preference, comparative clinical trial. The participants were provided with comprehensive information regarding each IOL option, including optical principles, expected visual outcomes, potential advantages, and associated limitations. Following detailed counseling and informed consent, patients selected their preferred IOL based on their individual needs, lifestyle requirements, and risk tolerance. The patient-preference design was selected over randomized controlled trial methodology for several considerations: first, to respect patient decision in IOL selection, which is standard practice in premium IOL surgery; second, to minimize ethical concerns associated with randomizing patients to potentially suboptimal treatments based on their individual needs; and third, to provide a real-world evidence regarding patient-chosen outcomes and satisfaction levels.

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 4, 2025
• Study Start: April 12, 2022
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)