Project Bidof - Monovision by Pairing Bifocal and EDOF Lens

Cataract Senile Clinical Trial

— Bidof  

Official title:

Project Bidof - Achieving Hybrid Monovision by Pairing Bifocal and EDOF Lens Technology

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05303571
• Other study ID #: KUK-Ophthalmology-005
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Cataract
• Cataract Senile

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