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RecruitingNCT07077967V(λ)'_EDOFUpdated Feb 24, 2026

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

An observational study in Presbyopia, sponsored by Democritus University of Thrace. Recruiting at 1 site in Greece. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Democritus University of Thrace · Observational

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
45 Years to 75 Years
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Presbyopia

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Keywords

  • pseudophakic presbyopic correction
  • EDOF intraocular lens
  • light intensity
  • eye light transmittance
  • light efficiency function
03

In context

Presbyopia

336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's planned enrollment of 100 is above the median of 88 across 52 observational studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Democritus University of Thrace is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Presbyopic patients who underwent pseudophakic presbyopic correction with EDOF intraocular lens implantation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age between 45 to 75 years

Exclusion criteria

Exclusion Criteria:

  • astigmatism >1.00 diopters
  • glaucoma
  • former incisional eye surgery
  • corneal or fundus disease
  • diabetes mellitus
  • diseases
  • neurological or psychiatric diseases
  • posterior capsule rupture or lens misalignment
  • postoperative uncorrected distance visual acuity \< 8/10.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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)

    Procedure: Phacoemulsification with EDOF IOLs

  • 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

  • ProcedurePhacoemulsification with EDOF IOLs

    Uneventful pseudophakic presbyopic correction with EDOF IOLs

06

What researchers measure

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.

    Time frame: 6 months postoperatively

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 34866900 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07077967
Lead sponsor
Democritus University of Thrace
Responsible party
Georgios Labiris (Associate Professor of Ophthalmology, Democritus University of Thrace) — Principal investigator
First posted
Jul 22, 2025
Start date
Oct 15, 2025
Primary completion
Oct 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Feb 24, 2026

Study contacts

Eirini - Kanella Panagiotopoulou, MD, MSc, PhD
Contact
panagiotopoulou.ek@gmail.com
+30 6978730858
Georgios Labiris, MD, Prof
Contact
labiris@usa.net
+30 2551030990
Georgios Labiris, MD, Prof
study chair · Democritus University of Thrace

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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