Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses

Intraindividual Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses Set for Emmetropia

Intra-individual comparison of the PureSee EDOF IOL with the Acunex Vario EDOF IOL set for emmetropia.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Low-Add EDOF IOL; Device: EDOF IOL

Detailed Description

Spectacle-independence is a growing goal in modern cataract surgery. The procedure has evolved from a simple restoration of vision to a presbyopia correction approach. Although bilateral monofocal IOL implantation with the goal of emmetropia results in high patient satisfaction for distance vision, spectacle-dependence for reading and intermediate vision tasks is the usual outcome.

Enhanced Depth of Focus (EDOF) lenses have been on the market for some time to minimize this spectacle-dependency in intermediate tasks (computer work, dashboard, etc.). These IOLs have an extended distance focal range that extends into the intermediate distance, providing high quality vision over a continuous focal range, rather than single foci with blurring in between. The risk to the patient is comparable to that of all other monofocal systems, which generally have high patient satisfaction. The benefit of this study should be continuous sharp binocular vision at distance, intermediate (66 cm) and even near (40 cm). Another expected effect is the reduction of dysphotopic phenomena compared to other EDOF lenses.

The aim of this study is to compare the visual performance of two refractive EDOF lenses, namely the Acunex Vario with the Puresee IOL, in an intraindividual comparative study design. In order to achieve a satisfactory result, we planned to include 40 patients scheduled for cataract surgery in the study.

The examinations will all take place one week before, 1 week and 4-6 months after the operation. These include a visual acuity check at the three distances mentioned, slit lamp examination, pressure control, biometry, pupil width, defocus curve, quality of vision questionnaires, contrast sensitivity, halo&glare, optical coherence tomography, fundus examination, aberrometry and keratometry.

The main parameter to be examined is the distance-corrected visual acuity for the intermediate distance (66 cm) between the two IOLs at the follow-up examination after 4-6 months.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age-related bilateral cataract
• Age 21 or older
• Visual acuity > 0.05
• For patients with regular corneal astigmatism greater than or equal to 1.00 dpt toric IOLs will be implanted
• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically relevant
• Written informed consent prior to surgery

Exclusion Criteria:

• Active ocular disease (e.g chronic uveitis, diabetic retinopathy, chronic glaucoma not responsive to medication, corneal dystrophies, etc.) precluding good post-operative visual acuity
• Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX)
• Corneal decompensation or corneal endothelial cell insufficiency
• Irregular astigmatism on corneal tomography
• Pronounced dry eye disease
• Previous ocular surgery or trauma
• Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acunex Vario AN6V; Patients will receive the Acunex IOL during cataract surgery	Device: Low-Add EDOF IOL; Acunex Vario AN6V
Experimental: PureSee; Patients will receive the PureSee IOL during cataract surgery	Device: EDOF IOL; PureSee EDOF IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance corrected visual acuity for intermediate distance	Distance corrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected visual acuity for intermediate distance	Uncorrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts	6 months
Uncorrected and distance corrected visual acuity for far distance	Uncorrected and distance corrected visual acuity for far distance given in logMAR will be measured at 4 m using ETDRS charts	6 months
Uncorrected and distance corrected visual acuity for near distance	Uncorrected and distance corrected visual acuity for near distance given in logMAR will be measured at 40 cm using ETDRS charts	6 months
Defocus curve assessment	Monocular defocus curves will be assessed in logMAR at 4 m using an ETDRS chart	6 months
Halometry	Potential halos will be assessed using the Aston Halometer App provided on a Tablet at 2 m	6 months
Contrast sensitivity	Contrast sensitivity will be tested using the Optec device	6 months
Subjective rating of dysphotopsia	Dysphotopsia will be subjectively rated by the patients using a questionnaire and a visual analogue scale	6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Cataract; EDOF IOL; presbyopia-correction
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Vario vs. PureSee

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No