Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses
Intraindividual Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses Set for Emmetropia
1 other identifier
interventional
40
1 country
1
Brief Summary
Intra-individual comparison of the PureSee EDOF IOL with the Acunex Vario EDOF IOL set for emmetropia.
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 Jul 2024
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
Study Start
First participant enrolled
July 29, 2024
CompletedFirst Submitted
Initial submission to the registry
September 19, 2024
CompletedFirst Posted
Study publicly available on registry
September 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedSeptember 23, 2024
September 1, 2024
11 months
September 19, 2024
September 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Distance corrected visual acuity for intermediate distance
Distance corrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts
6 months
Secondary Outcomes (7)
Uncorrected visual acuity for intermediate distance
6 months
Uncorrected and distance corrected visual acuity for far distance
6 months
Uncorrected and distance corrected visual acuity for near distance
6 months
Defocus curve assessment
6 months
Halometry
6 months
- +2 more secondary outcomes
Study Arms (2)
Acunex Vario AN6V
EXPERIMENTALPatients will receive the Acunex IOL during cataract surgery
PureSee
EXPERIMENTALPatients will receive the PureSee IOL during cataract surgery
Interventions
Eligibility Criteria
You may qualify if:
- Age-related bilateral cataract
- Age 21 or older
- Visual acuity \> 0.05
- For patients with regular corneal astigmatism greater than or equal to 1.00 dpt toric IOLs will be implanted
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically relevant
- Written informed consent prior to surgery
You may not qualify if:
- Active ocular disease (e.g chronic uveitis, diabetic retinopathy, chronic glaucoma not responsive to medication, corneal dystrophies, etc.) precluding good post-operative visual acuity
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX)
- Corneal decompensation or corneal endothelial cell insufficiency
- Irregular astigmatism on corneal tomography
- Pronounced dry eye disease
- Previous ocular surgery or trauma
- Persons who are pregnant or nursing (pregnancy test will be taken 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, Austria, 1140, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Findl, Univ. Prof. Prim. Dr.
Vienna Institute for Research in Ocular Surgery (VIROS)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 19, 2024
First Posted
September 23, 2024
Study Start
July 29, 2024
Primary Completion
July 1, 2025
Study Completion (Estimated)
July 1, 2026
Last Updated
September 23, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share