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OpenTrials
Completed

NCT Number: NCT05347615

Achieving Hybrid Monovision By Paring Monofocal 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 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.

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Key information

Conditions

Cataract Senile

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johannes Kepler University

Linz, 4020, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IOL Implantation:EDOF lens

Procedure

A EDOF lens is implanted in the dominant eye

IOL Implantation: Monofocal lens

Procedure

A monofocal lens is implanted in the non dominant eye.

Primary outcomes

  1. uncorrected distance visual acuity

    Time frame: 24 months

    Percentage of patients with uncorrected distance visual acuity of logMAR >0.1

  2. uncorrected intermediate distance visual acuity

    Time frame: 24 months

    Percentage of patients with uncorrected intermediate distance visual acuity of logMAR >0.2

  3. uncorrected near visual acuity

    Time frame: 24 months

    Percentage of patients with uncorrected near visual acuity of logMAR >0.2

Secondary outcomes

  1. Dysphotopsia

    Time frame: 24 months

    Quality of Vision questionnaire

  2. PRISQ-Questionnaire

    Time frame: 24 months

    questionnaire rating spectacle independency

  3. Patient Satisfaction

    Time frame: 24 months

    Catquest 9-SF-Questionnaire

Sponsors and collaborators

Lead sponsor

Johannes Kepler University of Linz

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2022
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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