Achieving Hybrid Monovision By Paring Monofocal And EDOF Lens Technology

Completed

• Conditions: Cataract Senile

• Registration Number: NCT05347615
• Lead Sponsor: Johannes Kepler University of Linz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-10
• Primary Completion: 2021-05-12
• Study Completion: 2021-05-12
• Status Verified: 2022-04
• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-04-20
• Last Update Submitted: 2022-04-20
• Study First Posted: 2022-04-26
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
uncorrected intermediate distance visual acuity	24 months	Percentage of patients with uncorrected intermediate distance visual acuity of logMAR \>0.2
uncorrected distance visual acuity	24 months	Percentage of patients with uncorrected distance visual acuity of logMAR \>0.1
uncorrected near visual acuity	24 months	Percentage of patients with uncorrected near visual acuity of logMAR \>0.2

Secondary Outcome Measures

Name	Time	Method
Dysphotopsia	24 months	Quality of Vision questionnaire
PRISQ-Questionnaire	24 months	questionnaire rating spectacle independency
Patient Satisfaction	24 months	Catquest 9-SF-Questionnaire

Trial Locations

Locations (1)

Johannes Kepler University; 🇦🇹 Linz, Austria