Visual Performance of an Extended Depth of Focus IOL in an Emmetropic or Monovision Modality
Difference in Visual Performance of a Refractive Extended Depth of Focus Intraocular Lens in an Emmetropic or Monovision Modality
1 other identifier
interventional
60
1 country
1
Brief Summary
Comparison of the visual performance of a refractive extended depth of focus intraocular lens in an emmetropic or monovision modality
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 Oct 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
First Submitted
Initial submission to the registry
October 1, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedFirst Posted
Study publicly available on registry
October 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
ExpectedOctober 3, 2024
October 1, 2024
1 year
October 1, 2024
October 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Corrected and uncorrected binocular visual acuity for near distance
Corrected and uncorrected binocular visual acuity for near distance will be assessed at 40 cm using ETDRS charts
12 months
Secondary Outcomes (4)
Corrected and uncorrected binocular visual acuity for distance
12 months
Corrected and uncorrected binocular visual acuity for intermediate distance
12 months
Contrast sensitivity
12 months
Subjective quality of vision
12 months
Study Arms (2)
PureSee Emmetropia
EXPERIMENTALPatient will receive the PureSee IOL with an emmetropic modality
PureSee Monovision
EXPERIMENTALPatient will receive the PureSee IOL in a monovision modality
Interventions
Eligibility Criteria
You may qualify if:
- Age-related bilateral cataract
- Age 21 or older
- Visual acuity \> 0.05
- Axial length: 21.00-27.00mm
- 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)
- 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
Vienna, Austria, 1140, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Findl, Prim. Prof. 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
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 1, 2024
First Posted
October 3, 2024
Study Start
October 1, 2024
Primary Completion
October 1, 2025
Study Completion (Estimated)
September 30, 2026
Last Updated
October 3, 2024
Record last verified: 2024-10