Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses
Intermediate Visual Acuity Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses
1 other identifier
interventional
35
1 country
1
Brief Summary
Comparison of the clinical performance of two enhanced monofocal IOLs with similar design.
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 Jun 2023
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 28, 2023
CompletedFirst Submitted
Initial submission to the registry
March 28, 2024
CompletedFirst Posted
Study publicly available on registry
April 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedApril 4, 2024
April 1, 2024
1.9 years
March 28, 2024
April 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Monocular intermediate visual acuity
Monocular intermediate visual acuity at 66 cm will be measured using ETDRS charts
24 months
Secondary Outcomes (2)
Monocular distance visual acuity
24 months
Monocular near visual acuity
24 months
Study Arms (2)
Evolux
EXPERIMENTALPatient will receive the Enova IOL during cataract surgery
Tecnis Eyhance
EXPERIMENTALPatient will receive the Tecnis Ehance IOL during cataract surgery
Interventions
Eligibility Criteria
You may qualify if:
- Bilateral cataract
- Age 21 or older
- Visual acuity \> 0.05
- Axial length: 22.00-26.00mm
- 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
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
You may not qualify if:
- Active ocular disease (e.g. chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS)
- Corneal decompensation or corneal endothelial cell insufficiency
- Amblyopia
- Previous ocular surgery or trauma
- Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
- Astigmatism with the need for a toric IOL
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, Prim. Dr.
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Krankenhaus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 28, 2024
First Posted
April 3, 2024
Study Start
June 28, 2023
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
April 4, 2024
Record last verified: 2024-04