Project Bidof - Monovision by Pairing Bifocal and EDOF Lens (Bidof)

Project Bidof - Achieving Hybrid Monovision by Pairing Bifocal and EDOF Lens Technology

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 mono- or bifocal 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 method is well established, the aim of this study is to compare the monofocal/EDOF cohort to the bifocal/EDOF cohort and evaluate visual acuity and patient satisfaction for both combinations.

Study Overview

• Status: Withdrawn
• Conditions: Cataract Senile

• Study Type: Observational

Contacts and Locations

Study Locations

• Austria
  • Upper Austria
    • Linz, Upper Austria, 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

• Sampling Method: Non-Probability Sample

Study Population

Patient between 21 and 99 years after cataract surgery

Description

Inclusion Criteria:

• Age between 21 and 99 years
• signed informed consent form
• condition after cataract surgery

Exclusion Criteria:

• no signed informed consent form
• laser treatment of the Cornea
• macular pathologies
• corneal pathologies
• irregular astigmatism
• pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Monodof; monofocal and EDOF lens
Bidof; Bifocal and EDOF lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Visual Acuity	percentage of patients with binocular distance corrected visual acuity of logMAR > 0.2	6 months
Intermediate Visual Acuity	percentage of patients with binocular intermediate distance corrected visual acuity of logMAR > 0.2	6 months
Near Visual Acuity	percentage of patients with binocular near visual acuity logmar < 0.2	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
contrast vision	contrast sensitivity vision	3 months
Halo and Glare	Halo and Glare Simulator	3 months
Defocus curve	Defocus curve	3 and 6 months

Collaborators and Investigators

• Sponsor: Johannes Kepler University of Linz

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): March 14, 2023
• Study Completion (Actual): March 14, 2023

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: KUK-Ophthalmology-005

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