Achieving Hybrid Monovision By Paring Monofocal And EDOF Lens Technology

Cataract Senile Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05347615
• Other study ID #: KUK-Ophthalmology-006
• Status: Completed
• Start date: October 10, 2019
• Est. completion date: May 12, 2021

Study information

• Verified date: April 2022
• Source: Johannes Kepler University of Linz
• Contact: n/a
• Is FDA regulated: No
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 12, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Senile

Intervention

Procedure:
• IOL Implantation:EDOF lens
A EDOF lens is implanted in the dominant eye
• IOL Implantation: Monofocal lens
A monofocal lens is implanted in the non dominant eye.

Locations

Country	Name	City	State
Austria	Johannes Kepler University	Linz

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	uncorrected distance visual acuity	Percentage of patients with uncorrected distance visual acuity of logMAR >0.1	24 months
Primary	uncorrected intermediate distance visual acuity	Percentage of patients with uncorrected intermediate distance visual acuity of logMAR >0.2	24 months
Primary	uncorrected near visual acuity	Percentage of patients with uncorrected near visual acuity of logMAR >0.2	24 months
Secondary	Dysphotopsia	Quality of Vision questionnaire	24 months
Secondary	PRISQ-Questionnaire	questionnaire rating spectacle independency	24 months
Secondary	Patient Satisfaction	Catquest 9-SF-Questionnaire	24 months