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OpenTrials
Completed

NCT Number: NCT05573529

EDOF and Multifocal IOL Study

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.

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Key information

Conditions

Age-related Cataract

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phacoemulsification and intraocular lens implantation

Procedure

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

Intraocular Lens Implantation

Device

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

Primary outcomes

  1. distant corrected near visual acuity

    Time frame: 6 months

    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.

Other outcomes

  1. Binocular Uncorrected Near Visual Acuity

    Time frame: 3 years

    Other outcome measure will be binocular uncorrected near visual acuity (UNVA) of each mix-and-match group. Binocular UNVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Comparison of Visual Outcomes and Patient Satisfaction After Bilateral Implantation of EDOF and Multifcoal IOLs- a Prospective Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Oct 10, 2022
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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