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Recruiting NCT07077967

Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections With EDOF IOLs

Observational Presbyopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Phacoemulsification with EDOF IOLs.
Who it may be relevant to
Registry conditions: Presbyopia. Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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)'

Overview

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.

Detailed description

Present study aims to identify in which degree EDOF IOLs modify eye light transmission and estimate the necessary task and environmental lighting adjustment in order to address lighting needs of patients following pseudophakic presbyopic corrections implanted with EDOF IOLs. Specifically, the aim of this study is to identify the minimum light intensity at which patients who underwent pseudophakic presbyopic correction with EDOF IOLs can reach their maximum visual acuity (measured when lights are at the 100% lighting level)

Interventions

  • Procedure Phacoemulsification with EDOF IOLs
    Uneventful pseudophakic presbyopic correction with EDOF IOLs

Primary outcome measures

  • Minimum Required Illuminance Level (MRIL) [Time frame: 6 months postoperatively]

Eligibility criteria

Inclusion criteria

  • age between 45 to 75 years

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Greece · 1 center
  • University Hospital of Alexandroupolis — Alexandroupoli

Publications

  • 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 34866900

Identifiers

NCT: NCT07077967 · ES5/Th9/13-02-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗