Performance of Two Intraocular Lenses With Extended Depth of Vision
Performance of Two Non-diffractive Intraocular Lenses With Extended Depth of Vision Set for Mini-monovision
1 other identifier
interventional
48
1 country
1
Brief Summary
Comparison of the capsular bag performance of two extended depth of vision (EDOF) intraocular lenses (IOLs), the Rayone EMV and the Alcon Acrysof IQ Vivity, in a mini-monovision setting
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Typical duration 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
First Submitted
Initial submission to the registry
January 3, 2022
CompletedStudy Start
First participant enrolled
January 3, 2022
CompletedFirst Posted
Study publicly available on registry
January 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2024
CompletedJanuary 18, 2022
January 1, 2022
1 year
January 3, 2022
January 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual acuity at intermediate distance
The visual acuity at the intermediate distance will be measured using ETDRS charts at a distance of 80 centimetres and compared between the two different IOLs
24 months
Secondary Outcomes (6)
Visual acuity at far distance
24 months
Visual acuity at near distance
24 months
Visual acuity in the defocus curve
24 months
Halometry
24 months
Contrast sensitivity
24 months
- +1 more secondary outcomes
Study Arms (2)
Rayone EMV
EXPERIMENTALPatient will receive the non-diffractive monofocal IOL during cataract surgery
Acrysof IQ Vivity
EXPERIMENTALPatient will receive the standard EDOF IOL during cataract surgery
Interventions
Eligibility Criteria
You may qualify if:
- age-related bilateral cataract
- age 21 or older
- visual acuity \> 0.05
- axial length: 22.0 - 26.0 mm
- normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- written informed consent prior to surgery
You may not qualify if:
- active ocular disease (e.g. chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)
- relevant othe rophthalmic diseases such as pseudoexfoliation syndrome (PEX), intraoperative floppy iris syndrome (IFIS)
- corneal decompensation or corneal endothelial cell insufficiency
- previous ocular surgery or trauma
- persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
- corneal astigmatism \> 1 dpt.
- retinopathies
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 3, 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