Intraindividual Comparison of EMO IOLs

Age Related Cataracts Clinical Trial

— EMO  

Official title:

Comparison of Visual Outcomes of Enhanced Monofocal Intraocular Lenses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05822089
• Other study ID #: 1631/2021
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: October 2023
• Source: Medical University of Vienna
• Contact: Christina Leydolt, MD
• Phone: +43 (01) 40 400 79480
• Email: christina.leydolt[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 283
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Age Related Cataracts
• Cataract

Intervention

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)
• 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)
• 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)
• 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
• 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)
• 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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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