Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05822089

Intraindividual Comparison of EMO IOLs

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age Related Cataracts

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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)
  • postoperativ binocular best corrected distance visual acuity (BCVA) ≥ 1.0 decimal (Arm ten (X))
  • Standard cataract surgery with bilateral implantation of a monofocal IOL (Vivinex XC1 or Vivinex XY1) (Arm ten (X))

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

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 of a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00)

Primary outcomes

  1. Distant corrected intermediate visual acuity

    Time frame: 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.

  2. Best-corrected distance visual acuity (BCDVA) - Acrysof IQ Vivity IOL, IC-8 Apthera IOL

    Time frame: 3-5 months

    Primary outcome measure will be monocular best-corrected distance visual acuity (BCDVA) of each intraocular lens implanted in 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.

  3. Contrast sensitivity and reading ability - Vivinex XC1 and Vivinex XY1

    Time frame: 2-6 months and 1-5 years

    Primary outcome measures for arm ten (X) will be the distance corrected contrast sensitivity and near corrected reading ability and reading speed. Contrast sensitivity will be assessed under standard photopic (85cd/m2) and mesopic (3cd/m2) conditions

Secondary outcomes

  1. Contrast sensitivity and reading ability

    Time frame: 2-6 months and 1-5 years

    Secondary outcome measures will be the distance corrected contrast sensitivity and near corrected reading ability and reading speed. Contrast sensitivity will be assessed under standard photopic (85cd/m2) and mesopic (3cd/m2) conditions.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Leydolt, MD

CONTACT

[email protected]

+43 (01) 40 400 79480

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Comparison of Visual Outcomes of Enhanced Monofocal Intraocular Lenses

Acronym: EMO

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2023
Registry last updated
Dec 5, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.