Intraindividual Comparison of EMO IOLs (EMO)

Comparison of Visual Outcomes of Enhanced Monofocal Intraocular Lenses

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.

Study Overview

• Status: Recruiting
• Conditions: Age Related Cataracts
• Intervention / Treatment: Procedure: phacoemulsification and intraocular lens implantation; Procedure: phacoemulsification and intraocular lens implantation; Procedure: phacoemulsification and intraocular lens implantation; Procedure: phacoemulsification and intraocular lens implantation; Procedure: phacoemulsification and intraocular lens implantation; Procedure: phacoemulsification and intraocular lens implantation

• Study Type: Interventional
• Enrollment (Estimated): 283
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina Leydolt, MD; Phone Number: +43 (01) 40 400 79480; Email: christina.leydolt@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • Medical University of Vienna
    • Contact: Christina Leydolt, MD; Phone Number: +4314040079480; Email: christina.leydolt@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Bilateral age-related cataract planned for phacoemulsification extraction and posterior IOL implantation
• Age 50 to 100
• Visual potential in both eyes of 20/25 or better as determined by investigators estimation
• Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

• Preceding intraocular surgery or ocular trauma
• Relevant other ophthalmic diseases that particularly effects the zonular apparatus (such as severe pseudoexfoliation syndrome, preceding cryocoagulation, trauma)
• Pupil diameter < 2.0 mm (photopic)
• Laser treatment
• Uncontrolled systemic or ocular disease
• Pregnancy/Nursing
• childbearing ability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monofocal IOL I vs. enhanced monofocal IOL I; The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm one (I) participants will receive a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00)	Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Sensar 1 AAB00) vs. an enhanced monofocal IOL (ICB00); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Vivinex XY1) vs. an enhanced monofocal IOL (Vivinex impress); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Vivinex impress) in both eyes; Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Acrysof IQ Vivity) in both eyes if irregular astigmatism is observed
Experimental: Monofocal IOL II vs. enhanced monofocal IOL I; The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm two (II) participants will receive a monofocal IOL (Sensar 1AAB00) vs. an enhanced monofocal IOL (ICB00)	Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Sensar 1 AAB00) vs. an enhanced monofocal IOL (ICB00); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Vivinex XY1) vs. an enhanced monofocal IOL (Vivinex impress); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Vivinex impress) in both eyes; Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Acrysof IQ Vivity) in both eyes if irregular astigmatism is observed
Experimental: Monofocal IOL III vs. enhanced monofocal IOL II; The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm three (III) participants will receive a monofocal IOL (Vivinex XY1)vs. an enhanced monofocal IOL (Vivinex Impress).	Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Sensar 1 AAB00) vs. an enhanced monofocal IOL (ICB00); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Vivinex XY1) vs. an enhanced monofocal IOL (Vivinex impress); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Vivinex impress) in both eyes; Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Acrysof IQ Vivity) in both eyes if irregular astigmatism is observed
Experimental: Enhanced monofocal IOL II vs. enhanced monofocal IOL II; The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm four (IV) participants will receive an enhanced monofocal IOL (Vivinex Impress) bilateral with a monovision target	Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Sensar 1 AAB00) vs. an enhanced monofocal IOL (ICB00); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Vivinex XY1) vs. an enhanced monofocal IOL (Vivinex impress); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Vivinex impress) in both eyes; Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Acrysof IQ Vivity) in both eyes if irregular astigmatism is observed
Experimental: Monofocal IOL III vs. enhanced monofocal IOL IV; The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm five (V) participants will receive an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart)	Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Sensar 1 AAB00) vs. an enhanced monofocal IOL (ICB00); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Vivinex XY1) vs. an enhanced monofocal IOL (Vivinex impress); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Vivinex impress) in both eyes; Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Acrysof IQ Vivity) in both eyes if irregular astigmatism is observed
Experimental: Enhanced Monofocal IOL V vs. enhanced monofocal IOL V with irregular astigmatism; The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm five (VI) participants will receive an enhanced monofocal IOL (Acrysof IQ Vivity) in both eyes if irregular astigmatism is observed.	Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Sensar 1 AAB00) vs. an enhanced monofocal IOL (ICB00); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Vivinex XY1) vs. an enhanced monofocal IOL (Vivinex impress); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Vivinex impress) in both eyes; Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart); Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Acrysof IQ Vivity) in both eyes if irregular astigmatism is observed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distant corrected intermediate visual acuity	Primary outcome measure will be monocular distant corrected intermediate visual acuity (DCIVA) of each intraocular lens implanted. DCIVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.	2-6 months
Best-corrected distance visual acuity (BCDVA) - Acrysof IQ Vivity IOL	Primary outcome measure will be monocular best-corrected distance visual acuity (BCDVA) of each intraocular lens implanted and eyes with irregular astigmatism. BCDVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.	3-5 months

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Christina Leydolt, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 1631/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No