EDOF and Multifocal IOL Study

Medical University of Vienna50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Age-related Cataract

Interventions

phacoemulsification and intraocular lens implantationPROCEDURE

bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation

intraocular lens implantationDEVICE

intraocular lens implantation includes EDOF IOL implantation in the dominant eye and multifocal IOL implantation in the non-dominant eye after phacoemulsification

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Vienna

Vienna, Vienna, Austria

Outcomes

Primary Outcomes

distant corrected near visual acuity

Primary outcome measure will be monocular distant corrected near visual acuity (DCNVA) of each intraocular lens implanted. DCNVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.