Intraindividual Comparison of EMO IOLs

Not Applicable

Recruiting

• Conditions: Age Related Cataracts
• Interventions: Procedure: phacoemulsification and intraocular lens implantation

• Registration Number: NCT05822089
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-13
• Study First Submitted: 2023-04-07
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-15
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 311

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
• Irregular Astigmatism (Acrysof IQ Vivity IOL, IC-8 Apthera IOL)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monofocal IOL III vs. enhanced monofocal IOL IV	phacoemulsification and intraocular lens implantation	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)
Enhanced monofocal IOL II vs. enhanced monofocal IOL II	phacoemulsification and intraocular lens implantation	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
Monofocal IOL I vs. enhanced monofocal IOL I	phacoemulsification and intraocular lens implantation	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)
Enhanced Monofocal IOL V vs. enhanced monofocal IOL V with irregular astigmatism	phacoemulsification and intraocular lens implantation	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.
Monofocal IOL II vs. enhanced monofocal IOL I	phacoemulsification and intraocular lens implantation	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)
Monofocal IOL III vs. enhanced monofocal IOL II	phacoemulsification and intraocular lens implantation	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).

Primary Outcome Measures

Name	Time	Method
Distant corrected intermediate visual acuity	2-6 months	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.
Best-corrected distance visual acuity (BCDVA) - Acrysof IQ Vivity IOL, IC-8 Apthera IOL	3-5 months	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.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria