Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections
Introduction of a Modified Luminous Efficiency Function V(λ)' That Addresses Total Light Transmittance of Patients That Underwent Pseudophakic Presbyopic Corrections
1 other identifier
observational
100
1 country
1
Brief Summary
Primary objective of this study is to construct and validate a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients that underwent bilateral pseudophakic presbyopic correction with trifocal 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 Jan 2020
Shorter than P25 for all trials
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
January 7, 2020
CompletedFirst Submitted
Initial submission to the registry
February 7, 2020
CompletedFirst Posted
Study publicly available on registry
February 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 30, 2021
March 1, 2021
12 months
February 7, 2020
March 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Minimum light intensity
Minimum light intensity in which participants reach their maximum critical visual acuity
6 months postoperatively
Secondary Outcomes (1)
Critical Visual Acuity (CVA)
6 months postoperatively
Study Arms (2)
Study group
Patients that underwent uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs (PanOptix or PanOptix toric, Alcon Laboratories, Inc., Fort Worth, TX, USA)
Control group
Patients of similar age without cataract that their crystalline lens has not been replaced.
Interventions
Uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs
Eligibility Criteria
Presbyopic patients that underwent pseudophakic presbyopic correction with bilateral trifocal intraocular lenses implantation
You may qualify if:
- age between 45 to 70 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 bilateral distant 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: 34866900DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Georgios Labiris, MD, PhD
Associate Professor
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
February 7, 2020
First Posted
February 11, 2020
Study Start
January 7, 2020
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
March 30, 2021
Record last verified: 2021-03