Intraindividual Comparison of EMO IOLs

Medical University of Vienna

Status

Enrolling

Conditions

Age Related Cataracts

Treatments

Procedure: phacoemulsification and intraocular lens implantation

Study type

Interventional

Funder types

Other

Identifiers

NCT05822089

1631/2021

Details and patient eligibility

About

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.

Enrollment

311 estimated patients

Sex

All

Ages

50 to 100 years old

Volunteers

No Healthy Volunteers

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)

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

311 participants in 7 patient groups

Monofocal IOL I vs. enhanced monofocal IOL I

Experimental group

Description:

Treatment:

Procedure: phacoemulsification and intraocular lens implantation

Monofocal IOL II vs. enhanced monofocal IOL I

Experimental group

Description:

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)

Treatment:

Procedure: phacoemulsification and intraocular lens implantation

Monofocal IOL III vs. enhanced monofocal IOL II

Experimental group

Description:

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).

Treatment:

Procedure: phacoemulsification and intraocular lens implantation

Enhanced monofocal IOL II vs. enhanced monofocal IOL II

Experimental group

Description:

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

Treatment:

Procedure: phacoemulsification and intraocular lens implantation

Monofocal IOL IV vs. enhanced monofocal IOL III

Experimental group

Description:

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)

Treatment:

Procedure: phacoemulsification and intraocular lens implantation

Enhanced Monofocal IOL IV vs. enhanced monofocal IOL IV with irregular astigmatism

Experimental group

Description:

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 six (VI) participants will receive an enhanced monofocal IOL (Acrysof IQ Vivity) in both eyes if irregular astigmatism is observed.

Treatment:

Procedure: phacoemulsification and intraocular lens implantation

Extended Depth of Focus IOL in eyes with irregular astigmatism

Experimental group

Description:

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 seven (VII) participants will receive an extended depth of focus IOL (IC-8 Apthera IOL) in one eye if irregular astigmatism is observed.

Treatment:

Procedure: phacoemulsification and intraocular lens implantation

Trial contacts and locations

Central trial contact

Christina Leydolt, MD

Data sourced from clinicaltrials.gov

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