NCT05194657

Brief Summary

Comparison of the visual function and reading performance between the Acrysof IQ Vivity IOL, an EDOF IOL, and the monofocal Acrysof IQ.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 4, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2024

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

January 4, 2022

Last Update Submit

January 4, 2022

Conditions

Cataract

Keywords

CataractCataract surgeryehanced depth of focus intraocular lens

Outcome Measures

Primary Outcomes (1)

  • Reading speed

    reading speed will be assessed with the Eyetracker device at 66 centimetres and will be compared between the EDOF IOL and the monofocal IOL

    24 months

Secondary Outcomes (1)

  • Visual acuity

    24 months

Study Arms (2)

Acrysof IQ Vivity

EXPERIMENTAL

Patient will receive the enhanced depth of focus IOL during cataract surgery

Device: enhanced depth of focus IOL

Acrysof IQ

EXPERIMENTAL

Patiet will receive the monofocal IOL during cataract surgery

Device: monofocal IOL

Interventions

enhanced depth of focus IOLDEVICE

Acrysof IQ Vivity, enhanced depth of focus IOL

Acrysof IQ Vivity
monofocal IOLDEVICE

Acrysof IQ, monofocal IOL

Acrysof IQ

Eligibility Criteria

Age21 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cataract
  • Stereopsis
  • age 21 and older
  • regular corneal astigmatism of up to 3.0 D
  • written informed consent prior to surgery
  • normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • german as mother-tongue
  • calculated IOL power needed is below 15.0 D or above 25.0 D (no high myopia or high hypermetropia will be recruited)

You may not qualify if:

  • relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract, corneal scars, and other co-morbidity that could affect capsule bag stability (e.g. Marfan syndrome) or retinal diseases affecting visual acuity (AMD, Macular Pucker, post-operative macular edema...)
  • amblyopia
  • contact lenses
  • irregular corneal astigmatism on corneal topography
  • postoperative subjective refraction smaller/ higher than or 0.75 D
  • pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Vienna, 1140, Austria

RECRUITING

Related Publications (1)

  • Amir-Asgari S, Georgiev S, Ruiss M, Plainis S, Pilwachs C, Findl O. Comparing postoperative reading performance and visual outcomes of a non-diffractive EDOF-IOL versus a monofocal IOL: a randomized controlled eye movement study. BMC Ophthalmol. 2025 Dec 24;25(1):694. doi: 10.1186/s12886-025-04507-9.

    PMID: 41444551DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Oliver Findl, MD

    Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sahand Amir-Asgari, MD

CONTACT

01 91021office@viros.at

Natascha Bayer, MSc

CONTACT

01 91021office@viros.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2022

First Posted

January 18, 2022

Study Start

January 3, 2022

Primary Completion

January 3, 2023

Study Completion

January 3, 2024

Last Updated

January 18, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)