Myopic Monovision: EDOF vs. Monofocal IOL
Comparison Between Bilateral Extended Depth of Focus (EDOF) Intraocular Lens Myopic Monovision and Monofocal Intraocular Lens Myopic Monovision for Myopic Patients: a Randomised Trial
1 other identifier
interventional
62
1 country
1
Brief Summary
Comparison of EDOF IOLs versus monofocal IOLs with mini-monovision concerning intermediate and near visual acuity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 4, 2022
CompletedFirst Posted
Study publicly available on registry
January 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedJanuary 18, 2022
January 1, 2022
6 years
January 4, 2022
January 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Spectacle independence
Spectacle independence will be assessed using a questionnaire and compared between patients with EDOF IOLs and patients with the monofocal IOL
24 months
Secondary Outcomes (3)
Visual acuity
24 months
Reading speed
24 months
Stereo vision
24 months
Study Arms (2)
Acunex Vario AN6V
EXPERIMENTALPatient will receive the enhanced depth of focus IOL during cataract surgery
Acunex AN6
EXPERIMENTALPatient will receive the monofocal IOL during cataract surgery
Interventions
Eligibility Criteria
You may qualify if:
- age-related cataract in both eyes
- bilateral cataract surgery
- motivated to be less spectacle dependent in the intermediate to near vision range
- expected CDVA of 0.8 snellen or better
- myopic patients with shorter eye having an axial length of at least 25.5 mm
- age 21 and older
- planned postoperative astigmatis lower than or 0.75 D
- written informed consent prior to recruitment
You may not qualify if:
- pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
- retinitis pigmentosa
- chronic uveitis
- amblyopia
- pupil decentration \> 0.8 mm, pupil size \< 2.8 mm
- preceded retinal surgery
- preceded LASIK
- any ophthalmic abnormality that could compromise visual function or the measurements
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Findl, MD
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Central Study Contacts
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
August 1, 2017
Primary Completion
August 1, 2023
Study Completion
August 1, 2024
Last Updated
January 18, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share