Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections With EDOF IOLs
V(λ)'_EDOF
Impact of Artificial Lighting on Visual Acuity After Presbyopia Correction With an Extended Depth of Focus Intraocular Lens: Introduction of a Modified Luminous Efficiency Function V(λ)'
1 other identifier
observational
100
1 country
1
Brief Summary
Primary objective of this study is to introduce a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients who underwent pseudophakic presbyopic correction with extended-depth of focus (EDOF) intraocular lenses (IOLs) implantations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2025
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
First Submitted
Initial submission to the registry
July 12, 2025
CompletedFirst Posted
Study publicly available on registry
July 22, 2025
CompletedStudy Start
First participant enrolled
October 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 15, 2026
February 24, 2026
February 1, 2026
1 year
July 12, 2025
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Minimum Required Illuminance Level (MRIL)
Minimum Required Illuminance Level (MRIL) (in lx) at which participants reach their optimal Uncorrected Distance Visual Acuity.
6 months postoperatively
Study Arms (2)
Study group
Patients who underwent uneventful pseudophakic presbyopic correction with yellow filter extended depth-of-focus (EDOF) IOLs (Vivity or Vivity toric, Alcon Laboratories, Inc., Fort Worth, TX, USA)
Control group
Patients of similar age who underwent uneventful cataract surgery implanted with yellow filter monofocal or monofocal toric IOLs (SN60WF or SN6ATx, Alcon Laboratories, Inc., Fort Worth, TX, USA)
Interventions
Uneventful pseudophakic presbyopic correction with EDOF IOLs
Eligibility Criteria
Presbyopic patients who underwent pseudophakic presbyopic correction with EDOF intraocular lens implantation
You may qualify if:
- age between 45 to 75 years
You may not qualify if:
- astigmatism \>1.00 diopters
- glaucoma
- former incisional eye surgery
- corneal or fundus disease
- diabetes mellitus
- autoimmune diseases
- neurological or psychiatric diseases
- posterior capsule rupture or lens misalignment
- postoperative uncorrected distance visual acuity \< 8/10.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100, Greece
Related Publications (1)
Labiris G, Panagiotopoulou EK, Taliantzis S, Perente A, Delibasis K, Doulos LT. Lighting Standards Revisited: Introduction of a Mathematical Model for the Assessment of the Impact of Illuminance on Visual Acuity. Clin Ophthalmol. 2021 Nov 28;15:4553-4564. doi: 10.2147/OPTH.S326139. eCollection 2021.
PMID: 34866900RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Georgios Labiris, MD, Prof
Democritus University of Thrace
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Ophthalmology
Study Record Dates
First Submitted
July 12, 2025
First Posted
July 22, 2025
Study Start
October 15, 2025
Primary Completion (Estimated)
October 15, 2026
Study Completion (Estimated)
December 15, 2026
Last Updated
February 24, 2026
Record last verified: 2026-02