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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05303571
Other study ID # KUK-Ophthalmology-005
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 14, 2022
Est. completion date March 14, 2023

Study information

Verified date March 2024
Source Johannes Kepler University of Linz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 14, 2023
Est. primary completion date March 14, 2023
Accepts healthy volunteers No
Gender All
Age group 21 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Johannes Kepler University Linz Upper Austria

Sponsors (1)

Lead Sponsor Collaborator
Johannes Kepler University of Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Distance Visual Acuity percentage of patients with binocular distance corrected visual acuity of logMAR > 0.2 6 months
Primary Intermediate Visual Acuity percentage of patients with binocular intermediate distance corrected visual acuity of logMAR > 0.2 6 months
Primary Near Visual Acuity percentage of patients with binocular near visual acuity logmar < 0.2 6 months
Secondary contrast vision contrast sensitivity vision 3 months
Secondary Halo and Glare Halo and Glare Simulator 3 months
Secondary Defocus curve Defocus curve 3 and 6 months
See also
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