EDOF and Multifocal IOL Study

Medical University of Vienna

Status: Completed

Conditions: Age-related Cataract

Treatments: Procedure: phacoemulsification and intraocular lens implantation; Device: intraocular lens implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05573529

1163/2020

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: 50 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
• Age 50-90
• Visual potential in both eyes of 20/30 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 ocular surgery or trauma
• Relevant other ophthalmic diseases (such as retinal degenerations, etc.)
• Uncontrolled systemic or ocular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Edof IOL vs. multifocal 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 one (I) participants will receive Edof IOL one (I) vs. multifocal IOL one (I).

Treatment:

Device: intraocular lens implantation

Procedure: phacoemulsification and intraocular lens implantation

Edof IOL vs. multifocal 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 two (II) participants will receive Edof IOL one (I) vs. multifocal IOL two (II).

Treatment:

Device: intraocular lens implantation

Procedure: phacoemulsification and intraocular lens implantation