Achieving Hybrid Monovision By Paring Monofocal And EDOF Lens Technology

The Implantation Of Monofocal And Premium IOL Models - A Registry Study At The Kepler University Hospital

Modern day cataract surgery isn't just a rehabilitative procedure anymore but rather aims at improving a patient's quality of life by reducing the need for spectacles in everyday life to a minimum. One way of achieving this goal is by using different lens technologies, such as a monofocal lens paired a lens with EDOF technology, as EDOF lenses provide an enhanced depth of focus by creating a single elongated focal point. As this "mix-and-match" is well established, the aim of this study is to compare the monofocal lens cohort to the EDOF lens cohort and evaluate visual acuity and patient satisfaction.

Study Overview

• Status: Completed
• Conditions: Cataract Senile
• Intervention / Treatment: Procedure: IOL Implantation:EDOF lens; Procedure: IOL Implantation: Monofocal lens

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4020
    • Johannes Kepler University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

male and female patients with senile cataract undergoing surgery

Description

Inclusion Criteria:

• Patient age between 21-99 years
• signed consent form
• senile cataract LOCS III grading
• Cataract surgery with monofocal or premium lens implantation

Exclusion Criteria:

• missing signed consent form
• macular pathologies
• corneal pathologies
• irregular astigmatism
• pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EDOF; Eye after EDOF lens Implantation	Procedure: IOL Implantation:EDOF lens; A EDOF lens is implanted in the dominant eye
Monofocal; Eye after Monofocal lens Implantation	Procedure: IOL Implantation: Monofocal lens; A monofocal lens is implanted in the non dominant eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
uncorrected distance visual acuity	Percentage of patients with uncorrected distance visual acuity of logMAR >0.1	24 months
uncorrected intermediate distance visual acuity	Percentage of patients with uncorrected intermediate distance visual acuity of logMAR >0.2	24 months
uncorrected near visual acuity	Percentage of patients with uncorrected near visual acuity of logMAR >0.2	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysphotopsia	Quality of Vision questionnaire	24 months
PRISQ-Questionnaire	questionnaire rating spectacle independency	24 months
Patient Satisfaction	Catquest 9-SF-Questionnaire	24 months

Collaborators and Investigators

• Sponsor: Johannes Kepler University of Linz

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2019
• Primary Completion (ACTUAL): May 12, 2021
• Study Completion (ACTUAL): May 12, 2021

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (ACTUAL): April 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: KUK-Ophthalmology-006

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