Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses

Intermediate Visual Acuity Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses

Comparison of the clinical performance of two enhanced monofocal IOLs with similar design.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Evolux; Device: Tecnis Eyhance

Detailed Description

In modern cataract surgery the aim of the procedure is not just the restoration of vision but to also achieve some spectacle independence. Bilateral implantation of monofocal intraocular lenses (IOL) aiming for emmetropia lead to high patient satisfaction levels in distance vision but leave patients dependent on spectacles in intermediate and near vision tasks.

To achieve high levels of spectacle independence the most commonly used option are multifocal intraocular lenses (MIOL). These MIOLs use either a refractive or diffractive optical design, a combination of both or segmented asymmetric optics. Usually, the characteristic diffractive ring patterns are incorporated on the posterior surface of an IOL, whereas the anterior lens surface remains purely refractive. However, a portion of patients experience problems with positive dysphotopsia symptoms such as halos and glare. Other potentially negative aspects of MIOLs are pupil size dependency and loss of light energy to higher order diffraction which can lead to reduced contrast sensitivity. In clinical studies diffractive lenses resulted in a better outcome in terms of optical quality, better contrast sensitivity and positive dysphotopsia phenomena than refractive multifocal lenses.

A newer concept of IOLs are non-diffractive enhanced range of vision (EROV) IOLs, sometimes also referred to as EDOF IOLs. The EROV IOLs with the least compromise concerning quality of vision are the group of so called enhanced monofocal IOL, also sometime referred to as monofocal plus IOL. These IOLs should result in better intermediate vison and provide contrast sensitivity and dysphotopsia results comparable to standard monofocal IOLs. These IOLs may be more adequate to meet the expectations of many presbyopic cataract patients, who were used to have a good distance vision and who were wearing spectacles when performing near vision tasks before surgery.

The aim of this study is to compare the clinical performance of a newer enhanced monofocal IOL (Evolux) with a standard enhanced monofocal IOL, the Tecnis Eyhance.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andreas Rotter, MD; Phone Number: 57564 01 91021; Email: office@viros.at
• Study Contact Backup: Name: Manuel Ruiss, MSc; Phone Number: 57564 01 91021; Email: office@viros.at

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Recruiting
    • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna
    • Contact: Andreas Rotter, MD; Phone Number: 57564 01 91021; Email: office@viros.at
    • Contact: Manuel Ruiss, MSc; Phone Number: 57564 01 91021; Email: office@viros.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Bilateral cataract
• Age 21 or older
• Visual acuity > 0.05
• Axial length: 22.00-26.00mm
• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
• Written informed consent prior to surgery
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

• Active ocular disease (e.g. chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)
• Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS)
• Corneal decompensation or corneal endothelial cell insufficiency
• Amblyopia
• Previous ocular surgery or trauma
• Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
• Astigmatism with the need for a toric IOL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evolux; Patient will receive the Enova IOL during cataract surgery	Device: Evolux; Evolux, enhanced monofocal IOL
Experimental: Tecnis Eyhance; Patient will receive the Tecnis Ehance IOL during cataract surgery	Device: Tecnis Eyhance; Tecnis Eyhance, enhanced monofocal IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular intermediate visual acuity	Monocular intermediate visual acuity at 66 cm will be measured using ETDRS charts	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular distance visual acuity	Monocular distance visual acuity at 4 meters will be measured using ETDRS charts	24 months
Monocular near visual acuity	Monocular near visual acuity at 40 cm will be measured using ETDRS charts	24 months

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery
• Investigators: Principal Investigator: Oliver Findl, Prim. Dr., Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Krankenhaus

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cataract surgery; Cataract; Intraocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Evolux

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No