Visual Performance of an Extended Depth of Focus IOL in an Emmetropic or Monovision Modality

Difference in Visual Performance of a Refractive Extended Depth of Focus Intraocular Lens in an Emmetropic or Monovision Modality

Comparison of the visual performance of a refractive extended depth of focus intraocular lens in an emmetropic or monovision modality

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Emmetropic modality; Device: Monovision modality

Detailed Description

With an expanding market of different types of intraocular lenses (IOL), spectacle independence is a rising aim in modern cataract surgery. The procedure has in many cases changed from a vision restoring to a presbyopia correcting approach. Although bilateral monofocal IOL implantation, aiming for emmetropia, leads to high levels of patient satisfaction for distance vision, spectacle dependence for reading and intermediate vision tasks is the usual result.

The option commonly used to achieve spectacle independence at intermediate distance (e.g., PC work) is the implantation of enhanced depth of focus (EDOF) IOLs. These IOLs have an extended far focus area which reaches to the intermediate distance, providing high-quality vision over a continuous range of focus, rather than distinct foci with blur in between. In the last years several technologies for EDOF IOLs appeared on the market. The spectrum ranges from small aperture design, bioanalogic design, to diffractive and non-diffractive optics. The disadvantage compared to monofocal lenses in all the technologies mentioned is the potentially worse distance vision and contrast sensitivity as well as dysphotopsia.

A new refractive EDOF lens segment with an extended depth of vision was introduced which promises an increased range of functional vision and less dysphotopsias compared to diffractive EDOF lenses. These non-diffractive IOLs are believed to be a presbyopia correcting alternative for people with existing corneal or macula pathologies, which would preclude them from receiving premium lenses because of the loss of light in the diffractive process. To increase spectacle independence for these patients, IOLs may be used in a monovision modality, with an offset of up to 1.5dpt. This method showed good results in the literature so far for monofocal and multifocal intraocular lenses.

Aim of the study is to compare a new non-diffractive EDOF-IOL, namely the PureSee, set for emmetropia or monovision.

120 eyes of 60 patients will be included into this study. Patients will be either randomized in the emmetropia or the monovision group

Follow-up visits will be 1 week after each surgery and 3 months post-surgically. During these visits, the clinical variables to be assessed will be visual acuity, stereopsis, contrast sensitivity, and binocular defocus curves.

• Study Type: Interventional
• Enrollment (Estimated): 60
• 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: Natascha Bayer, MSc; Phone Number: 01 91021 57564; Email: office@viros.at

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Recruiting
    • Vienna Institute for Research in Ocular Surgery
    • Contact: Johannes Zeilinger, MD; Phone Number: 01 91021 57564; Email: office@viros.at
    • Contact: Natascha Bayer, MSc; 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
• Axial length: 21.00-27.00mm
• 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)
• 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: PureSee Emmetropia; Patient will receive the PureSee IOL with an emmetropic modality	Device: Emmetropic modality; PureSee IOL, emmetropic modality
Experimental: PureSee Monovision; Patient will receive the PureSee IOL in a monovision modality	Device: Monovision modality; PureSee IOL, monovision modality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected and uncorrected binocular visual acuity for near distance	Corrected and uncorrected binocular visual acuity for near distance will be assessed at 40 cm using ETDRS charts	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected and uncorrected binocular visual acuity for distance	Corrected and uncorrected binocular visual acuity for distance will be assessed at 4 m using ETDRS charts	12 months
Corrected and uncorrected binocular visual acuity for intermediate distance	Corrected and uncorrected binocular visual acuity for intermediate distance will be assessed at 66 cm using ETDRS charts	12 months
Contrast sensitivity	Contrast sensitivity will be tested using the Optec Vision tester under mesopic and photopic conditions with and without an additional glare source	12 months
Subjective quality of vision	Subjective quality of vision will be assessed using a questionnaire	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

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

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: PureSee MiniMonovision

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
• product manufactured in and exported from the U.S.: No