NCT05347615

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

1.6 years

First QC Date

April 20, 2022

Last Update Submit

April 20, 2022

Conditions

Cataract Senile

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Dysphotopsia

    24 months

  • PRISQ-Questionnaire

    24 months

  • Patient Satisfaction

    24 months

Study Arms (2)

EDOF

Eye after EDOF lens Implantation

Procedure: IOL Implantation:EDOF lens

Monofocal

Eye after Monofocal lens Implantation

Procedure: IOL Implantation: Monofocal lens

Interventions

IOL Implantation:EDOF lensPROCEDURE

A EDOF lens is implanted in the dominant eye

EDOF
IOL Implantation: Monofocal lensPROCEDURE

A monofocal lens is implanted in the non dominant eye.

Monofocal

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

male and female patients with senile cataract undergoing surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes Kepler University

Linz, 4020, Austria

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Ophthalmology

Study Record Dates

First Submitted

April 20, 2022

First Posted

April 26, 2022

Study Start

October 10, 2019

Primary Completion

May 12, 2021

Study Completion

May 12, 2021

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)